Methods for data processing for intra-operative navigation systems

ABSTRACT

Disclosed are methods and systems used with surgical navigation systems that enable a user to generate an optimized anatomical dataset for a spine level of interest. The systems and methods allow users to determine a target geometry for a spinal level targeted for spinal surgery. Additionally, the user can project loads across the spinal orthopedic implants and determine a projected subsidence over time.

CROSS-REFERENCE

This application claims the benefit of U.S. Provisional Application No.62/171,861 filed Jun. 5, 2015, entitled Methods for Determining theTarget Geometry for a Level Targeted for Spinal Surgery, for Determiningthe Safe Operating Range of Spinal Joints During Surgery, and forModeling and Projecting Various Loads Across Spinal Orthopedic Implants,and U.S. Provisional Application No. 62/187,930 filed Jul. 2, 2015,entitled Methods for Determining the Target Geometry for a LevelTargeted for Spinal Surgery, for Determining the Safe Operating Range ofSpinal Joints During Surgery, and for Modeling and Projecting VariousLoads Across Spinal Orthopedic Implants, and U.S. ProvisionalApplication No. 62/268,138 filed Dec. 16, 2015, entitled Methods andSystems for Managing Spinal Surgery in an Operating Environment, whichapplications are incorporated herein by reference.

BACKGROUND OF THE INVENTION

One of the most prevalent joint problems is back pain, particularly inthe “small of the back” or lumbosacral (L4-S1) region. In many cases,the pain severely limits a person's functional ability and quality oflife. Such pain can result from a variety of spinal pathologies. Throughdisease or injury, the vertebral bodies, intervertebral discs, laminae,spinous process, articular processes, or facets of one or more spinalvertebrae can become damaged, such that the vertebrae no longerarticulate or properly align with each other. This can result in anundesired anatomy, loss of mobility, and pain or discomfort. DukeUniversity Medical Center researchers found that patients suffering fromback pain in the United States consume more than $90 billion annually inhealth care expenses, with approximately $26 billion being directlyattributable to treatment. Additionally, there is a substantial impacton the productivity of workers as a result of lost work days. Similartrends have also been observed in the United Kingdom and othercountries.

As part of the diagnostic process of determining the cause of paincoming from a joint such as the lumbar spine, health care providers relyon an understanding of joint anatomy and mechanics when evaluating asubject's suspected joint problem and/or biomechanical performanceissue. Currently available orthopedic diagnostic methods are capable ofdetecting a limited number of specific and treatable defects. Thesetechniques include X-Rays, MRI, discography, and physical exams of thepatient. In addition, spinal kinematic studies such as flexion/extensionX-rays are used to specifically detect whether or not a joint hasdysfunctional motion. These methods have become widely available andbroadly adopted into the practice of treating joint problems andaddressing joint performance issues.

What us needed are new devices and methods for determining the targetgeometry for a level targeted for spinal surgery. Additionally, devicesand methods for the safe operating range of spinal joints duringsurgery. Still other needs include devices and methods for modeling andprojecting various loads across spinal orthopedic implants.

SUMMARY OF THE INVENTION

Disclosed are devices and methods for determining the target geometryfor a level targeted for spinal surgery. Additionally, disclosed aredevices and methods for the safe operating range of spinal joints duringsurgery. Also included are devices and methods for modeling andprojecting various loads across spinal orthopedic implants.

An aspect of the disclosure is directed to a machine readable mediumcontaining instructions stored on a non-transitory computer readablemedium that, when executed by a computing device, cause the computingdevice to perform a method, the method comprising: receiving an inputdataset comprising one or more medical images containing a spine levelof interest for a patient; and generating an optimized anatomicaldataset for the spine level of interest wherein the optimized anatomicaldata set comprises one or more of a target disc height, a targetanterior-posterior offset, and a target lordosis angle, and furtherwherein the step of generating an optimized anatomical dataset for thespine level of interest comprises the steps of: identifying zero, one ormore visible spine levels in the one or more medical images to excludefrom analysis; and accessing one or more image-derived measurements of adisc height measurement, an anterior-posterior offset measurement, and asagittal lordosis angle measurement for one or more non-excluded spinelevels; and applying a function to the one or more measurements fromaccessing one or more image-derived measurements to generate anoptimized value for the spine level of interest for one or more of thetarget disc height, the target anterior-posterior offset, and the targetlordosis angle. The optimized anatomical data set can comprises two ormore of a target disc height, a target anterior-posterior offset, and atarget lordosis angle. Additionally, the function can receive an inputand applies one or more adjustments to correct for an assumedpost-operative subsidence of an interbody device over time. In at leastsome configurations, the one or more adjustments is a disc heightadjustment, an anterior-posterior offset adjustment, and a lordosisangle adjustment. The one or more medical images excluded from analysiscan be excluded independently for one or more of an excluded disc heightmeasurement, an excluded anterior-posterior offset, and an excludedsagittal lordosis angle. The function can also be one of an averagefunction and a distribution function, and further wherein an input isselected from a medical literature. A surgical navigation system usermay also specify a gross lordosis target for an entire region of a spineand wherein the function distributes one or more gross lordosis regionaltargets across a user-specified set of levels targeted for fusionsurgery.

Another aspect of the disclosure is directed to a processor forgenerating estimates of a weight carried at a spine level of interest,wherein the processor is programmed to execute: accessing an inputdataset for a patient comprising a weight of the patient, one or moreimage-derived measurements of a spatial relationships between two ormore vertebral bodies visible within one or more images; allowing a userto specify a spine level of interest; and projecting an estimated weightcarried at the spine level of interest by: looking-up one or more valuesfrom a previously published mass distribution function, wherein the massdistribution function comprises a set of percentage values associatedwith various bodily regions such that the sum of the set of percentagevalues equals 100%; summing x from the mass distribution functionelements for all bodily regions cranial to a spinal region of interest;calculating y from the image-derived measurements of the spatialrelationships between vertebral bodies from the input dataset, bydetermining an estimated percentage of the region of interest that iscranial to a spinal level of interest; summing x and y; and multiplyingthe sum of x and y by a weight of the patient to determine the weightcarried at the spine level of interest. Additionally, the processor isconfigurable to calculate a sheer and a compressive component of theweight carried at the spine level of interest, using the image-derivedmeasurements of the angulation between vertebral body endplates and aplumb line. In at least some configurations, the input dataset containspatient-specific data and wherein the computational routine incorporatesa lookup function that returns a mass distribution which is a functionof the patient-specific data. The patient-specific data can be selectedfrom, for example, age, gender, and height. Additionally, the previouslypublished mass distribution function is one selected by the user fromamong a set of available functions.

Still another aspect of the disclosure is directed to a processor foruse with surgical navigation systems used for spinal surgery wherein theprocessor is programmed to execute: receiving an input datasetcomprising one or more medical images containing a spine level ofinterest; and generating measurements of an operating range of the spinelevel of interest, comprising measurements of at least one of a minimumlinear displacement between a pair of adjacent vertebral bodycorner-points from the spine level of interest and a maximum lineardisplacement between a pair of adjacent vertebral body corner-pointsfrom the spine level of interest by executing a computational processcomprising: accessing one or more medical images containing the spinelevel of interest from the input dataset, and further accessing one ormore measurements from each image of at least one of the minimum lineardisplacement and the maximum linear displacement; and applying at leastone of a maximum function and a minimum function to the measurement setsto determine a maximum linear displacement value for a pair of adjacentcorner points and a minimum linear displacement values for the pair ofadjacent corner-points; and rendering data usable by a surgicalnavigation system based on the operating range measurements. Therendering of data usable by a surgical navigation system can support avisual display of the operating range measurements by the surgicalnavigation system. Additionally, the data rendered can trigger an alertto a surgical navigation system user when the operating rangemeasurement for the spine level of interest is outside of auser-determined threshold value.

Yet another aspect of the disclosure is directed to a processor for usewith a surgical navigation system used for spinal surgery that whereinthe processor is programmed to execute: receiving an input datasetcomprising one or more medical images, wherein each medical imageincludes an image of a spinal level of interest, one or moreimage-derived measurements for each medical image wherein the one ormore image-derived measurements are selected from an alignmentmeasurement, a lordosis measurement, a translation measurement, anangulation measurement, and a disc height measurement; allowing a userto specify a data presentation by selecting one or more of theimage-derived measurements and by further selecting at least one of aminimum value and a maximum value; identifying a specific image viewcorresponding to the data presentation wherein an output of anidentification process is a reference to an image that corresponds tothe user specified data presentation; and generating comparative databetween a current status of the patient wherein the generatedcomparative data uses a measurement from one or more image capturedintra-operatively via the surgical navigation system and the datapresentation. The measurement of interest can include measurements thatare derivative to the input dataset. Additionally, the comparative datagenerated includes one or more of a generated image with a template, agenerated image without a template, and a generated image compiled frommultiple imaging modalities.

Another aspect of the disclosure is directed to a processor for use witha surgical navigation system used for spinal surgery wherein theprocessor is programmed to execute: receiving a pre-operative datasetand an inter-operative dataset, wherein each of the pre-operativedataset and inter-operative dataset comprises one or more medical imagescontaining a spine region of interest as well as a dataset of locationvalues associated with a four-point registration of each vertebral bodyvisible within the spine region of interest; allowing a user of thesurgical navigation system to specify an input dataset for eachvertebral body pair within the spine region of interest; and rendering ablock diagram of a spine, by using the four-point registration datasetfrom the input dataset selected by the user.

An aspect of the disclosure is directed to a machine readable mediummeans containing instructions stored on a non-transitory computerreadable medium means that, when executed by a computing device means,cause the computing device means to perform a method, the methodcomprising: receiving an input dataset comprising one or more medicalimages containing a spine level of interest for a patient; andgenerating an optimized anatomical dataset for the spine level ofinterest wherein the optimized anatomical data set comprises one or moreof a target disc height, a target anterior-posterior offset, and atarget lordosis angle, and further wherein the step of generating anoptimized anatomical dataset for the spine level of interest comprisesthe steps of: identifying zero, one or more visible spine levels in theone or more medical images to exclude from analysis; and accessing oneor more image-derived measurements of a disc height measurement, ananterior-posterior offset measurement, and a sagittal lordosis anglemeasurement for one or more non-excluded spine levels; and applying afunction to the one or more measurements from accessing one or moreimage-derived measurements to generate an optimized value for the spinelevel of interest for one or more of the target disc height, the targetanterior-posterior offset, and the target lordosis angle. Additionally,the function can receive an input and applies one or more adjustments tocorrect for an assumed post-operative subsidence of an interbody deviceover time. In at least some configurations, the one or more adjustmentsis a disc height adjustment, an anterior-posterior offset adjustment,and a lordosis angle adjustment. The one or more medical images excludedfrom analysis can be excluded independently for one or more of anexcluded disc height measurement, an excluded anterior-posterior offset,and an excluded sagittal lordosis angle. The function can also be one ofan average function and a distribution function, and further wherein aninput is selected from a medical literature. A surgical navigationsystem user may also specify a gross lordosis target for an entireregion of a spine and wherein the function distributes one or more grosslordosis regional targets across a user-specified set of levels targetedfor fusion surgery.

Another aspect of the disclosure is directed to a processor means forgenerating estimates of a weight carried at a spine level of interest,wherein the processor means is programmed to execute: accessing an inputdataset for a patient comprising a weight of the patient, one or moreimage-derived measurements of a spatial relationships between two ormore vertebral bodies visible within one or more images; allowing a userto specify a spine level of interest; and projecting an estimated weightcarried at the spine level of interest by: looking-up one or more valuesfrom a previously published mass distribution function, wherein the massdistribution function comprises a set of percentage values associatedwith various bodily regions such that the sum of the set of percentagevalues equals 100%; summing x from the mass distribution functionelements for all bodily regions cranial to a spinal region of interest;calculating y from the image-derived measurements of the spatialrelationships between vertebral bodies from the input dataset, bydetermining an estimated percentage of the region of interest that iscranial to a spinal level of interest; summing x and y; and multiplyingthe sum of x and y by a weight of the patient to determine the weightcarried at the spine level of interest. Additionally, the processor isconfigurable to calculate a sheer and a compressive component of theweight carried at the spine level of interest, using the image-derivedmeasurements of the angulation between vertebral body endplates and aplumb line. In at least some configurations, the input dataset containspatient-specific data and wherein the computational routine incorporatesa lookup function that returns a mass distribution which is a functionof the patient-specific data. The patient-specific data can be selectedfrom, for example, age, gender, and height. Additionally, the previouslypublished mass distribution function is one selected by the user fromamong a set of available functions.

Still another aspect of the disclosure is directed to a processor meansfor use with surgical navigation system means used for spinal surgerywherein the processor means is programmed to execute: receiving an inputdataset comprising one or more medical images containing a spine levelof interest; and generating measurements of an operating range of thespine level of interest, comprising measurements of at least one of aminimum linear displacement between a pair of adjacent vertebral bodycorner-points from the spine level of interest and a maximum lineardisplacement between a pair of adjacent vertebral body corner-pointsfrom the spine level of interest by executing a computational processcomprising: accessing one or more medical images containing the spinelevel of interest from the input dataset, and further accessing one ormore measurements from each image of at least one of the minimum lineardisplacement and the maximum linear displacement; and applying at leastone of a maximum function and a minimum function to the measurement setsto determine a maximum linear displacement value for a pair of adjacentcorner points and a minimum linear displacement values for the pair ofadjacent corner-points; and rendering data usable by a surgicalnavigation system based on the operating range measurements. Therendering of data usable by a surgical navigation system means cansupport a visual display means of the operating range measurements bythe surgical navigation system means. Additionally, the data renderedcan trigger an alert to a surgical navigation system user when theoperating range measurement for the spine level of interest is outsideof a user-determined threshold value.

Yet another aspect of the disclosure is directed to a processor meansfor use with a surgical navigation system means used for spinal surgerythat wherein the processor means is programmed to execute: receiving aninput dataset comprising one or more medical images, wherein eachmedical image includes an image of a spinal level of interest, one ormore image-derived measurements for each medical image wherein the oneor more image-derived measurements are selected from an alignmentmeasurement, a lordosis measurement, a translation measurement, anangulation measurement, and a disc height measurement; allowing a userto specify a data presentation by selecting one or more of theimage-derived measurements and by further selecting at least one of aminimum value and a maximum value; identifying a specific image viewcorresponding to the data presentation wherein an output of anidentification process is a reference to an image that corresponds tothe user specified data presentation; and generating comparative databetween a current status of the patient wherein the generatedcomparative data uses a measurement from one or more image capturedintra-operatively via the surgical navigation system and the datapresentation. The measurement of interest can include measurements thatare derivative to the input dataset. Additionally, the comparative datagenerated includes one or more of a generated image with a template, agenerated image without a template, and a generated image compiled frommultiple imaging modalities.

Another aspect of the disclosure is directed to a processor means foruse with a surgical navigation system means used for spinal surgerywherein the processor means is programmed to execute: receiving apre-operative dataset and an inter-operative dataset, wherein each ofthe pre-operative dataset and inter-operative dataset comprises one ormore medical images containing a spine region of interest as well as adataset of location values associated with a four-point registration ofeach vertebral body visible within the spine region of interest;allowing a user of the surgical navigation system to specify an inputdataset for each vertebral body pair within the spine region ofinterest; and rendering a block diagram of a spine, by using thefour-point registration dataset from the input dataset selected by theuser.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.See, for example, U.S. Pat. No. 8,676,293 issued Mar. 18, 2014 to Breenfor Devices, systems and methods for measuring and evaluating the motionand function of joint structures and associated muscles, determiningsuitability for orthopedic intervention, and evaluating efficacy oforthopedic intervention; U.S. Pat. No. 8,777,878 issued Jul. 15, 2014,to Deitz for Devices, systems, and methods for measuring and evaluatingthe motion and function of joints and associated muscles and U.S. Pat.No. 7,502,641 issued Mar. 10, 2009, to Breen for Method for imaging therelative motion of skeletal segments

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 illustrates two pairs of vertebral bodies which illustrates anormal pair and an offset pair;

FIGS. 2A-D illustrates a method for determining a target geometry for aspine surgery which allows a user to select a construct and provide forany exclusions (FIG. 2A), the vertebral bodies represented as rectanglesillustrating PDH, ADH and offset (FIG. 2B), an image legend of maximum,current values, and minimum (FIG. 2C), and an application of the imagelegend to an exemplar pair of vertebral bodies represented by rectangles(FIG. 2D);

FIG. 3A illustrates a hardware diagram having a computer incommunication with an analog video port and a surgical C arm, FIG. 3Billustrates a home screen for software;

FIG. 4 illustrates the Capture Image functionality (a first function ofthe system);

FIGS. 5A-C illustrate the Confirm Position functionality (a secondfunction of the system);

FIGS. 6A-B illustrate the Navigate functionality (a third function ofthe system);

FIG. 7 illustrates an exemplar screen for a Rothenfluh configuration;

FIG. 8 illustrates an exemplar screen for a Roussouly configuration;

FIGS. 9A-B illustrates sagittal alignment maps for Rothenfluhconfiguration and Roussouly configuration;

FIG. 10 illustrates an exemplar mark-up diagram;

FIG. 11 illustrates exemplar data for lordosis at a plurality of spinallevels;

FIG. 12 illustrates an exemplar geometric transformation calculation;and

FIG. 13A-C illustrate methods for projecting loads.

DETAILED DESCRIPTION

One aspect of the present disclosure relates to a method for determiningthe target geometry of a spinal fusion surgical construct. Radiographicimages of a patient's spine are acquired via any radiographic imagingmethod. From these images, specific measurements can be collected atlevels not targeted for surgery from images collected while a patient isstanding in a neutral position, including: anterior disc height,posterior disc height, offset (i.e. intervertebral translation), and/orangulation. These measurements are then used to generate apatient-specific average from the levels imaged but not targeted forsurgery. These averages are then used to determine a set of targetparameters for a surgical construct. These target parameters may then beused as the input to a surgical navigation system or may be used by thesurgeon during surgery for device selection or to assist with thesurgery. FIG. 1 illustrates two vertebral bodies in a currentorientation and a target orientation with anterior disc height (ADH),posterior disc height (PDH) and offset.

As shown in FIGS. 2A-D a system user can select or exclude constructsfor a plurality of vertebral pairs. For example, a patient targeted forsurgery at L4/L5 may have lumbar spine radiographic images. Measurementsof ADH, PDH, and Intervertebral translation (IVT) are then collected atLevels L1/L2, L2/L3, L3/L4, and potentially L5/S1, and averaged acrossthese levels. These average parameters are the output of this method.The user may opt to delete specific levels from this averagecalculation, as shown in FIG. 2A.

Once these averages have been tabulated by the system, the user can viewthe resulting construct. The construct is as a series of points on alateral and/or anterior-posterior projection of the anatomy. As will beappreciated the construct could also be a series of points on a 3Dmodality such as magnetic resonance imaging (MRI) or computed tomography(CT). These construct points may be manipulated by the user as shown inFIGS. 2B-D.

The data describing the target construct is created in a way that it isavailable for use by the surgical navigation system, having incorporatedphysician-specific assumptions as well as patient-specific data fromprior diagnostic studies, such that it is unnecessary for any specificpre-surgical planning work step on the part of the surgeon. Thisworkflow may incorporate image processing services that do processing ofimages and external reviews by radiologists. This workflow may alsoincorporate pre-rendered paper or pdf reports that allow targetconstructs parameters to be accessed by a user.

The system reduces workflow by enabling a user to determine whether apatient moves under a gravitational load of about 20%. Thus, whenpositioning a patient, the user can quickly determine whether it wouldbe effective to attempt to get the level to open or reduce (i.e., is thelevel at its maximum mobility). Quantitative feedback provides assuranceto the surgeons which results in increased definitive decision making inthe operating room. Additionally, the systems is configurable to provideactionable new data. For example, the system can alert a user or surgeonwhen a “pharmaceutical reduction” is occurring. Information about, forexample, a pharmaceutical reduction, can change a surgical decision fromdecompression to fusion. Additionally, the system is configurable withno touch constructs. Thus a surgeon can analyze the projected impact ofdifferent surgical constructions which takes into consideration, forexample, implant size, anticipated subsidence, sheer and compressiveloads, and PI-LL. The system also allows for confirmation of implantplacement.

Once target construct has been determined, then intra-operative feedbacksystems can be used during surgery to assess current status of thegeometry of a patient's spine surgery construct at a level or levelsrelative to the target construct's parameters as described above. Thiscould be accomplished by having a fluoroscopic imaging device connectedto a computer-mounted piece of frame-grabbing hardware configurable todigitize an image which could then undergo registration of the discspace on the image by a user (i.e., the space between two vertebralbodies in the spine). Once registered, this system would compare theregistered image against the target and provide feedback to a surgeonuser as to how much more a construct's geometry needs to be changed toachieve the target geometry. See FIGS. 3A-B, 4, and 6A-B.

This system is configurable to allow the user to incorporate variousassumptions about levels of subsidence of device implants. This couldmean that a target construct is sized to be larger than what is desiredto be achieved post-operatively after patient recovery, so that aftersubsidence occurs the construct achieves the target construct geometry.This system is also configurable to allow the user to see the effects ofthe target construct on pre-operative parameters such as (Pelvicincidence minus lumbar lordosis) as well as the type of implant devicedimensions that would be required to achieve the surgical construct.These parameters (target construct geometry, implant dimensions,projected forces, pelvic incidence minus lumbar lordosis, etc.) can allbe changed dynamically, and when one parameter is changed the effect ofthe change is displayed for all other parameters. In addition the systemcan allow the user to configure a user-defined set of assumptions aboutthe magnitude and distribution of projected subsidence. Theseassumptions could additionally be affected by surgeon input, such as thesurgeon inputting data that the patient has osteoporosis or otherwisehas bad bone quality, is obese, elderly, scoliotic, or other factorsthat could affect subsidence. Subsidence assumptions could be furtherpersonalized to a specific patient based on projected compressivegravitational loads across an implant. See FIG. 6A.

A second aspect of the disclosure is a method for determining the safeoperating range of spinal joints during surgery. This method involvesthe use of a system that can assess the operating range of spinal levels(in terms of intervertebral rotation/angulation and translation) as aninput device. Data for each level of the spine that has been measured isprovided regarding the maximum and minimum observed rotation,translation, anterior disc height, and posterior disc height, asmeasured from a range of bending and load conditions. These rangestherefore represent the ranges to which spinal levels will go undervoluntary movement conditions, which represents the sub-acute range withrespect to potential ligamentous injury that could occur during spinalsurgery due to external compressive or distractive forces applied by thesurgeon during surgery. Such compressive and distractive forces areoften applied during spinal surgery, during patient positioning whensurgeons often attempt to induce maximum lordosis at a level, whendetermining the size and geometric/spatial configuration of the implantrelative to the disc space, and when assessing of implanted hardware hasbeen properly placed and configured. Image data from a previousdiagnostic study could be available and accessible intraoperatively so asurgeon could selectively view the anatomy in specific positions, suchas most lordotic, most kyphotic, most reduced, greatest anterior discheight, least anterior disc height, greatest posterior disc height,least posterior disc height, greatest opening to patient left, leastopening to patient left, greatest opening to patient right, or leastopening to patient right. See FIG. 6B.

This data about the minimum and maximum observed range of motion is thenused with an intra-operative feedback systems to assess current statusof the geometry of a patient's spine surgery construct at a level orlevels relative to the minimum and maximum operating range of that joint(as described directly above). This could be accomplished by having afluoroscopic imaging device connected to a computer-mounted piece offrame-grabbing hardware that could digitize an image which could thenundergo registration of the disc space on the image by a user. Onceregistered, this system would compare the registered image against theminimum and maximum data and provide feedback to a surgeon user as towhere the current anatomy is relative to its maximum and minimumdemonstrated operating range. See FIG. 6A.

A third aspect of the disclosure includes a system for assisting withthe positioning of a patient on an operating table prior to a surgery.Data from previous diagnostic studies of intervertebral motion would beavailable for comparison to a current position as captured using theframe grabber and fluoroscopic imaging device (as previously described).During patient positioning prior to surgery, the surgeon is often tryingto achieve a specific position for a level targeted for spine surgery,such as maximum lordosis or most reduced. Using data from prior imagingstudies along with a registered image taken during the patientpositioning routine that occurs prior to surgery, the surgeon couldcompare a current position to the level's known range of operation todetermine how much more positioning, if any, is required to achieve thetarget position for surgery. In the case that a patient that isanesthetized reduces more than has been observed on prior imagingstudies, an alert could be triggered. See FIGS. 5A-C.

According to an embodiment of the disclosure, there is a lengthyrequirements specification for a product that is capable of achievingthe objects of the first through third aspects above, as well as otherobjectives. This requirements specification is provided in its entiretybelow, after which a fourth aspect of the disclosure is provided.

The systems can be summarized as having exemplar hardware features, andexemplar functional features.

Hardware Features:

-   -   The system can be IEC60601-compliant    -   The system can be a console mounted computer.    -   The system can have encrypted fixed media.    -   The system can allow for frame capture of an analog input from a        surgical C-arm    -   The system can have the following hardware user interfaces:        Mouse; Keyboard; USB Media port; Main monitor; Slave monitor.    -   The system typically does not include: External/network        connectivity; or Touchscreen input capabilities

Functional Features: Overall Application:

-   -   The system can consist of an application that loads upon        boot-up.    -   The system can be locked down, so that users can only access the        system software application, and none of the resident functions        within windows, unless a user presses a keystroke that will be        known only to technicians.    -   The system can require a user to login using a username and        password or a username and by answering security questions    -   The system can be shut down via user controls within the system        Software.    -   Every screen of the software can feature a company or product        logo, the system software version number, and the current        date/time    -   There can be 3 major screens: Splash/Login Screen; Main Screen;        Capture Screen    -   There can be one or more of the following modal windows: Load        New Patient; Load Previous Session; Edit disc height (A1); Edit        offset (A2); Edit Lordosis (A3); Lordosis Distribution        Calculations, Rothenfluh (B1); Lordosis Distribution        Calculations, Roussouly (B1); Edit Correction for Anticipated        Subsidence (C1); and Calibrate (D)    -   Typically, there are be three main user types for the system:        -   Surgeon: A surgeon can access any and all functionality of            the system. The surgeon can access all previous patients            saved to this system, and optionally (a site-level            parameter) can open patients from any other surgeon who has            saved cases to the system.        -   OR Admin: The OR Administrator is an operating room            administrator who can access any patient saved to the system            and all functionality except making edits on the            configuration screen (they can view, but not change the            data)        -   System Administrator: The System Administrator can change            site level parameters and reset passwords for OR Admin and            Surgeon users.    -   The input data for the system software is typically provided as        an encrypted file to protect patient privacy that is accessed        via USB media, and that was created by an online system as a        rendered patient data package. See the “Input File Features”        section for more details about this input file.

Functional Features: Data Saving and Storage

-   -   For each use session, the system can store one or more of at        least:        -   all actions taken by all users during all use sessions,            excluding simple navigation. The actions that can be stored            are defined as those that can affect any data structure            within the system software system.        -   a log a time/date/user stamp along with the action being            taken.        -   the default configuration values associated with a surgeon            user at the initialization of a use session, and changes to            these configuration values made during the session.        -   the input data file.    -   The system can be configurable to recall any instance of a user        session. This may be done by saving each instance before it is        changed, or by storing sufficient data during each user session        such that any instance of a user session can be reconstructed.    -   The system is also configurable to store each testing event in a        first in, first out (FIFO) queue        -   The queue system can use all allotted hard disc space,            deleting older testing events first as more hard drive space            is needed.        -   If and when the system is deleting older testing events, the            system can present a message to the user prior to the            deletion and allow the user to cancel the delete action.    -   The system is configurable to store the following information        for each user:        -   Data associated with each ADMIN user including, Username,            password, and password help questions.        -   Data associated with each SURGEON user including, User            config variables, and acceptance status of the click through            agreement, plus date/time of acceptance; and Username,            password, and password help questions.        -   Site level parameters and data that gest stored:            -   The system is configurable to log all successful and                unsuccessful login attempts.            -   Site configuration variable: Can Surgeons access                patients created by other Surgeons?    -   To retrieve data from the system, the system is configurable to        store data in such a way that it is accessible to a system        trained technician by executing the technician Keystroke, then        doing a manual copy of files from the system to removable media.        This storage process can be fulfilled once a file structure        exists that is accessible via the WINDOWS file explorer (or        equivalent function) for copying to external media.

Functional Features: Video Frame Capture

-   -   The system is configurable to connect to an output port on a        C-arm of the type DVI (capable of supporting both analog and        digital signals). See. FIG. 3A.        -   Adapters can be used as needed or desired, to convert            between DVI and other ports such as BNC, VGA, and others.    -   The system is configurable to:        -   Receiving a live video stream from the C-arm, for display by            the software        -   Upon command, digitizing a current frame of the live video            stream, and saving that image as a file that is usable by            the software.

Splash/Login Screen:

-   -   Users can enter usernames, either by free text edit or by        accessing a drop down list of existing user accounts that have        been created on the system.    -   Users can enter a password or provide answers to security        questions, in order to log into the system. Alternative means of        authentication can be used without departing from the scope of        the disclosure including RFID control, biometric data, and the        like. Upon login:        -   If the user is a Surgeon type: check to see if: (1) the user            typically has not been through the click throughs in the            User Configuration pages, or (2) the user configuration            pages have changed. If so, the user gets put into the            configuration pages and can't progress to the Main Screen            until the click through agreement has been agreed to.        -   The system can be capable of popping up the instructions for            use (IFU) with click-through acknowledgement for the user's            first login, and each time the IFU is updated.        -   The system is configurable to provide pop-up custom messages            with a click-through acknowledgment, for assuring that all            users are informed of updates such as release notes when            software is updated and other messages.    -   Users can be able to create new user accounts.    -   Users can provide security questions and answers in the case        that passwords cannot be remembered by the user.    -   Passwords can be resettable by system administrator users.    -   Users can be able to select “remember me”, which will pull up        the prior username upon initialization of the Splash/Login        Screen    -   Users may also initiate a shutdown

Main Screen

-   -   The Main Screen can be comprised of the following elements:        -   A first row of buttons (with User Manual, Load Patient, and            Exit buttons)        -   A second row of buttons (with the Report, Capture,            Calibrate, and Configure. In at least some configurations,            the Report and Capture buttons can only appear after a            patient has been loaded).        -   A left pane, which can assume three states            -   Sagittal Alignment Diagram            -   Lumbar View            -   Disc Space View        -   A right pane, which can assume two states:            -   Surgery Summary            -   Level Summary        -   With respect to how the left and right panes are displayed:            -   The initial default view (upon first coming to the Main                Page) can be the Sagittal Alignment Diagram (left pane)                and Surgery Summary (right pane).            -   The left and right pane can be independently changed by                clicking a tab contained in a row of tabs at the top of                each of the left and right panes.    -   The following can be visible and active to all users under all        user scenarios:        -   On the first row of buttons:            -   Users can access an “Exit” button. Upon clicking the                Exit button, users may be presented with the option to                “Exit patient” (which puts user back on the surgery                summary screen in its state when no patient has been                loaded), “Logoff [USER]” (which puts the user back on                the splash/login screen), and “Shutdown” (which                initiates a shutdown sequences            -   Users can also access a “Load Patient” button, which                pops up the “Load New Patient” Modal Window.                -   Prior to popping up the “Load New Patient” modal                    window, if an existing patient is loaded, user is                    warned that loading a new patient will close the                    current patient.            -   Users can be able to access a “User Manual” button,                which pops up the current version of the user manual in                a pdf viewer window.        -   On the second row of buttons:            -   Users can be able to access a “Calibrate” modal window                by pressing a button                -   Prior to calibration there can be a ghosted,                    mismatched crosshair icon presented on the button.                -   After calibration there can be one sharp crosshair,                    and the label changes to “RECALIBRATE”.            -   Users can be able to access a “Configure” button, that                navigates the patient to the CONFIGURATION screen    -   The following can be visible and active to all users once a        patient has been loaded:        -   On the left pane of the window, there can be:            -   A series of tabs across the top section of the left                pane. There can be seven tabs: “L1/L2”, “L2/L3”,                “L3/L4”, “L4/L5”, “L5/S1”, “Sagittal Alignment Diagram”,                “View Lumbar Images”                -   On each of the five tabs associated with the five                    lumbar levels, there can also be a check box and a                    label saying “Fusion?”            -   In the case that user config specifies the Roussouly                method, then when the status variable [ADDITIONAL                LORDOSIS FOR SA CORRECTION STATUS]=“Not Confirmed” AND                on the Surgery Summary object, the value in the                “Additional Lordosis for Sagittal Alignment Corrections”                edit box is not-zero, then:                -   the tab for each level (“L1/L2”, “L2/L3”, “L3/L4”,                    “L4/L5”, “L5/S1”) can be inactive/ghosted, although                    the user can still be able to select a level for                    fusion for one of the levels (via the checkbox                    included in the tab).                -   There can be a prominent message to the user, with                    graphic objects such as arrows, that show that the                    user can either edit the value or press the OK                    button (these appear in the Surgery Summary in the                    middle section) to proceed to the Disc Space View.                    Without such messaging, the user may not have the                    knowledge as to why the tabs are ghosted and how to                    get to Disc Space View.            -   A main section of the left pane, which can be configured                to contain one of three objects: Sagittal Alignment                Diagram, Disc Space View, and View Lumbar Images. The                user navigates to the three objects by selecting the                appropriate tab (the tabs with the “L1/L2” . . . “L5/S1”                labels take the user to Disc Space View). Each of these                three objects is described in a subsequent dedicated                section of this document.        -   On the right pane of the window, there can be:            -   A series of tabs across the top section of the right                pane. There can be three tabs: “Surgery Summary”, “Level                Summary”, or “Capture”.            -   A main section of the right pane, which can contain one                of two objects: Surgery Summary Object or the Level                Summary Object. The pane is selectable by the user by                clicking one of the tabs.            -   If the user selects “Capture”, then the “Capture” Screen                can appear, which comprises a specific design for the                left and right panes of the screen and is described in                Detail in the “Capture” Section of this document.            -   If [ACTIVE LEVEL] is null, then the “Level Summary” tab                can be inactive/ghosted. (see the Status Variable                section of this document for more information about the                [ACTIVE LEVEL] variable).        -   On the second row of buttons:            -   A “Report” button can be visible, which can pull up the                report as a pdf document within a pdf viewer. The pdf                viewer can occupy the entire window, and the only                navigation available to the user at that point is “Done”                and “Exit”.                -   Once a user exits, if they re-open the viewer, it                    can automatically resume at the last page the user                    was looking at.            -   A “Capture” button can be visible, which can pull up the                “Capture” Screen, which comprises a specific design for                the left and right panes of the screen and is described                in Detail in the “Capture” Section of this document.

Main Screen, Right Pane: Surgery Summary

-   -   There can be a matrix of objects, arranged as a table, which can        include:        -   Row Labels for each level “L1/L2” . . . “L5/S1”        -   A column of Checkboxes to specify a level for fusion            -   Specifying a level can check all three of the “exclude”                boxes (from disc height, offset such that the two                vertebra are not perfectly aligned, and lordosis                calculations) associated with that level.            -   These check boxes can be synchronized with the fusion                checkboxes on the tabs at the top of the left pane.        -   A column space direction to the right of the column of            checkboxes that may display alert icons whenever alerts are            activated for a given patient use session and for a specific            level that has been selected for fusion surgery. The user            can move the mouse over the icon mouse to present text            appropriate with each activated alert. For more detailed            features about the behavior of these alerts, see the “Alerts            Features” section of this document.        -   A set of three columns of checkboxes labeled “Model            Exclusions”            -   Deselecting the check box has no effect of the status of                the checkboxes that indicate which levels are selected                for fusion.            -   Each of the second and the third columns (Disc Height                and Offset) can independently be either active or                ghosted/inactive based on whether the value for the Disc                Height and/or Offset status variable [CHECKBOX COLUMNS                ACTIVE] is TRUE or FALSE (respectively).            -   For each row of checkboxes, selecting that row to                receive fusion system can automatically select the three                checkboxes. Deselecting the check box has no effect on                the select/deselect status of the checkboxes that                indicate a level is selected to receive fusion.            -   The three columns system can contain:                -   A column of Checkboxes to exclude a level from                    Lordosis calculations with the column header label                    “Lordosis”                -   A column of Checkboxes to exclude a level from disc                    height average calculations with the column header                    label “Disc Height”                -   A column of Checkboxes to exclude a level from                    offset average calculations with the column header                    label “Offset”                -   Edit button to edit Lordosis, that takes you to the                    “Edit Lordosis” (Modal window)                -   Edit button to edit disc height, that takes you to                    the “Edit Disc Height” (Modal window)                -   Edit button to edit offset, that takes you to the                    “Edit Offset” (Modal window)        -   A column of labels/dropdown labeled “Lordosis Data Source”            -   For levels that have not been selected for fusion, this                can be a static label that can be visible for all levels            -   For level that are selected for surgery, there system                can a drop-down instead of just a label:                -   If there has not been a capture, then this is                    defaulted to “Target” and the values in the drop                    down are, for example, “Target”, and other labels                -   If they have undergone a capture, this is defaulted                    to capture and the values in the drop down can be                    “Capture”, “Target”, and other labels.    -   There can be a middle section, which system can assume one of        two configurations, based on the user configuration selection of        either the “Rothenfluh” or the “Roussouly” method for        determining Sagittal Alignment corrections.        -   For users configured to the “Rothenfluh” selection, there            can be:            -   A title label: “Edit/Confirm Additional Lordosis to                Correct Sagittal Alignment”            -   A matrix of information:                -   A row of five labels: “Pre-Op”, “Change vs Pre-Op:                    Segmental Lordosis (summed across all fusion                    levels)”, “L1-S1 Sagittal Alignment Correction”,                    “Correction for Anticipated Subsidence (summed                    across all fusion levels)”, and “Post-Op”                -    Next to the “Change vs Pre-Op: Segmental Lordosis                    (summed across all fusion levels)” label, there can                    be an edit button that pops up the Edit Lordosis                    modal window.                -    Next to the “L1-S1 Sagittal Alignment Correction”                    label, there can be an edit button that pops up the                    appropriate modal window from the set (Lordosis                    Distribution Calculations, Rothenfluh B1; and                    Lordosis Distribution Calculations, Roussouly B2)                    based on the value in User Config.                -    Next to the “Correction for Anticipated Subsidence                    (summed across all fusion levels)” label, there can                    be an edit button that pops up the Edit Correction                    for Anticipated Subsidence modal window.                -   Underneath each label, there can be a value in                    degrees (rounded to the nearest whole number).                -    On the leftmost and rightmost of these values:                -    there can be a label “PI-LL=” to the left of the                    displayed values.                -    there can be space to display a single alert icon                    (either yellow or red) plus the short text “SA”. For                    more detailed features about the behavior of these                    alerts, see the “Alerts Features” section of this                    document.                -    On the middle three of these values, the value is                    given as “+” or “−” a number to the left of the                    value.                -    On the value under the label “L1-S1 Sagittal                    Alignment Correction”, there can be:                -    a single edit box with up/down increment buttons,                    which becomes active and non-null whenever at least                    one level is selected for fusion. See the                    “Calculations Features” section for the behavior of                    the variable in the edit box                -    There can be an “OK” Button that is active whenever                    the edit box value is non-zero AND the status                    variable [ADDITIONAL LORDOSIS FOR SA CORRECTION                    STATUS] is set to “Not Confirmed” (See the Status                    Variable Features section of the document). Once                    either of these two actions is done, the OK button                    is invisible.                -    A label “Computed value based on default settings”,                    along with the value in degree units rounded to the                    nearest whole number with either a “+” or “−” next                    to the number as appropriate.            -   FIG. 7 is a graphical representation of the features for                the middle section for the “Rothenfluh” configuration:        -   For users configured to the “Roussouly” selection, there can            be:            -   A title label: “Enter Any Desired Corrections to                Upper/Lower Lumbar Arcs”            -   A simple diagram on the left side of the middle section:                -   A line angled to the angle of the superior edge of                    L1 in standing uncontrolled neutral, next to the                    label “L1”                -   A line with a label “Apex of lumbar curve” pointing                    to another label “LX” where “LX” is a variable set                    to the value of the apex of the lumbar curve (See                    the Calculations Features section for more                    information about the lumbar apex calculation).                -   A line angled to the angle of the superior edge of                    S1 in standing uncontrolled neutral, next to the                    label “S1”.            -   A matrix of information, including:                -   A row of five column header labels: “Pre-Op”,                    “Change vs Pre-Op: Segmental Lordosis (summed across                    all fusion levels)”, “L1-S1 Sagittal Alignment                    Correction”, “Correction for Anticipated Subsidence                    (summed across all fusion levels)”, and “Post-Op”                -    Next to the “Change vs Pre-Op: Segmental Lordosis                    (summed across all fusion levels)” label, there can                    be an edit button that pops up the Edit Lordosis                    modal window.                -    Next to the “L1-S1 Sagittal Alignment Correction”                    label, there can be an edit button that pops up the                    appropriate modal window from the set (Lordosis                    Distribution Calculations, Rothenfluh B1; and                    Lordosis Distribution Calculations, Roussouly B2)                    based on the value in User Config.                -    Next to the “Correction for Anticipated Subsidence                    (summed across all fusion levels)” label, there can                    be an edit button that pops up the Edit Correction                    for Anticipated Subsidence modal window.                -   Two row header labels: “Upper Arc” and “Lower Arc”.                -   A 5×2 array of data, showing values in degree units,                    rounded to the nearest whole number/                -    On the middle three of these values, the value is                    given as “+” or “−” a number to the left of the                    value.                -    For the two values in the column labeled “L1-S1                    Sagittal Alignment Correction”, these can be edit                    boxes with up/down increment buttons.                -    The defaulted value can be zero                -    If no levels are selected for surgery in the upper                    arc, then the upper arc edit box can be ghosted and                    not editable. The same system can apply to the lower                    arc edit box.            -   A row of information, with the label “Lordosis Type”,                with the lordosis type underneath both the “PRE-OP” and                “POST-OP” columns, and being able to assume the values                1, 2, 3, or 4.            -   A row of information, with the label “Pelvic Tilt”, with                the Pelvic Tilt value underneath both the “PRE-OP” and                “POST-OP” columns, and being a value in degree units                that is rounded to the nearest whole number.            -   There can be two spaces, each one able to show a                triangle icon, either yellow or red, plus the short text                “SA”. Each alert icon/short text is horizontally spaced                next to the each of the two columns of data associated                with “Lordosis Type” and “Pelvic Tilt” (as described                directly above), and vertically spaced between those two                rows. See the “Alerts Features” Section for more                specification about the conditions that various alerts                become active.            -   FIG. 8 is a graphical representation of the features for                the middle section for the “Roussouly” configuration:

Main Screen, Right Pane: Level Summary

-   -   In the case that the [ACTIVE LEVEL] is not selected for fusion,        there can be no visible objects in this panel. (note: See the        section Main Screen for more info about the [ACTIVE LEVEL]        variable).    -   In the case that the [ACTIVE LEVEL] is selected for fusion,        there can be two sub-panels: An upper sub-panel for Surgical        Considerations and lower one for Lordosis Analysis:        -   The upper sub-panel for Surgical Considerations system can:            -   Have a label which says “[ACTIVE LEVEL] Surgical                Considerations”            -   Display up to three alerts, each one comprising an icon                and alert text. See the Alerts Features section of the                features document for more details about features for                these alerts.        -   The lower sub-panel for Lordosis Analysis system can:            -   Have a label which says “[ACTIVE LEVEL] Lordosis                Analysis”            -   There can be a matrix of values, comprising:                -   A row of four column heading labels: “Expected                    Lordosis @ [ACTIVE LEVEL]”, “Sagittal Alignment                    Correction”, “Correction for Anticipated                    Subsidence*”, and “Segmental Lordosis Target”.                -    Next to the “Expected Lordosis @ [ACTIVE LEVEL]”                    label, there can be an edit button that pops up the                    Edit Lordosis modal window.                -    Next to the “Sagittal Alignment Correction” label,                    there can be an edit button that pops up the                    appropriate modal window from the set (Lordosis                    Distribution Calculations, Rothenfluh B1; and                    Lordosis Distribution Calculations, Roussouly B2)                    based on the value in User Config.                -    Next to the “Correction for Anticipated                    Subsidence*” label, there can be an edit button that                    pops up the Edit Correction for Anticipated                    Subsidence modal window.                -   Underneath the column headers, in the second through                    the fourth column can be an editable text box,                    arranged in a row beneath the row of column                    headings, with up/down increment buttons, and                    defaulted to the computed value. This row can have                    the row heading of “Target Construct”                -    In that same row, underneath the column header in                    the first column, there can be a value for expected                    Lordosis at [ACTIVE LEVEL].                -   Underneath the “Target Construct” row described                    above, there is another row of degree values (#°,                    one for each column, with the row heading of                    “Computed Values based on default settings.”                -   See “Calculation Features” section for more details                    about the values that are displayed in these boxes.                -   Underneath the “Computed Values” row, aligned with                    the “Correction for Anticipated Subsidence” column,                    there can be a label for “Maximum Anticipated                    Anterior Subsidence*”, and underneath that there can                    be an editable text box with up/down increment                    buttons and containing a value in millimeter units                    (#.# mm)                -   There can be a label in red next to the editable                    text box “Maximum Anticipated Anterior Subsidence”                    that says “Default value was adjusted down because                    gravity is acting nearly parallel to the level”.                    This label only appears if there has been an                    automatic reduction to the default MAAS value (see                    the Calculation Features section for more details                    about the conditions when this can occur).                -   There can be a label at the very bottom of the panel                    that displays a note explaining what is meant by the                    asterisk next to the labels “Correction for                    Anticipated Subsidence*” and “Maximum Anticipated                    Anterior Subsidence*”. That label system can say “*                    This estimate of potential lordosis loss due to                    subsidence is a geometric calculation based on the                    individual vertebral body dimensions of each                    patient. This calculation uses an assumed “Maximum                    Anticipated Anterior Subsidence” which represents                    the upper end of expected subsidence. Consider                    adjusting upward from the default value when patient                    has poor bone quality or when interbody device                    placement is posterior. Consider adjusting downward                    from the default if the level receives anterior                    fixation or when interbody device placement is                    anterior.”                -   See “Calculation Features” section for more details                    about the values that are displayed in these boxes,                    including the default values and how these values                    change.

Main Screen, Left Pane: Sagittal Alignment Diagram

-   -   There can be block diagrams of the anterior column of the spine,        based on the coordinates of each vertebral body from the        standing uncontrolled neutral view.        -   The diagram can be updated with any change to:            -   The set of levels selected for fusion.            -   The lordosis data source specified at a level            -   The target construct geometry, for levels specified to                draw lordosis data from the target construct. Target                construct geometry can be changed by a number of user                actions. Any of the items that can change the target                construct can also therefore trigger an update to the                Sagittal Alignment diagram.            -   A capture, for levels specified to draw lordosis data                from a capture    -   Each vertebral body can be labeled    -   The femoral head can be represented by two circles.    -   There can be the following lines overlaid:        -   A. A line along the top of L1        -   B. Two diagonal lines overlaid on L1, connecting opposing            corners        -   C. A line perpendicular to A that intersects with the            intersection of the diagonal lines in B, and extends to the            intersection of E        -   D. A line along the top of S1        -   E. A line perpendicular to D that intersects D at the            midpoint of the upper edge of S1.        -   F. A line connecting the center points of the femoral head            circles.        -   G. A line originating at the midpoint of F and extending to            the intersection of D and E.        -   H. A line originating at the intersection of D and E            extending along the horizontal        -   I. A line originating at the midpoint of F and extending            upward along the plumb line.        -   J. Labels: PI, PT, SS, and LL.    -   There can be a vertical plumb line, with a label: “Gravity”        -   The Sagittal Alignment Diagram can be oriented such that the            plumb line aligns with the vertical axis of the page.    -   There can be a matrix of data:        -   Row Labels: “LL=”, “SS=”, “PI=”, and “PT=”        -   Values can be presented next to each label, in degree units            rounded to the nearest whole number.    -   For users that are configured for the “Rothenfluh” method for        determining Sagittal Alignment corrections, the additional        following objects can be present in the Sagittal Alignment        Diagram:        -   There can be a label at the bottom “PI-LL=”, along with the            PI-LL Value            -   There can be space to show a single triangle icon,                either yellow or red, plus short text, based on whether                or not the Sagittal Alignment alert is activated. See                the “Alerts Features” Section for more specification                about the conditions that various alerts become active.        -   There can be a label “Lordosis Type X (Roussouly)”, wherein            the “X” is the Roussouly Type, and can assume the value 1,            2, 3, or 4. See the Calculations Features section for more            information about the function to determine the Roussouly            Lordosis Type.    -   For users that are configured for the “Roussouly” method for        determining Sagittal Alignment corrections, the additional        following objects can be present in the Sagittal Alignment        Diagram:        -   There can be a label “Lordosis Type X (Roussouly)”, wherein            the “X” is the Roussouly Type, and can assume the value 1,            2, 3, or 4.        -   There can be a label “Pelvic Tilt” as well as the pelvic            tilt value given in degree units rounded to the nearest            whole number.        -   There can be space to show a single triangle icon, either            yellow or red, plus short text, horizontally spaced next to            the two values associated with “Lordosis Type” and “Pelvic            Tilt” (as described directly above), and vertically spaced            between those two rows. See the “Alerts Features” Section            for more specification about the conditions that various            alerts become active.        -   A Label that says “APEX” positioned next to the appropriate            vertebral body label. [NOTE: In some prior designs, this was            the “APEX” label plus an arrow pointing to a vertebral body.            This design was abandoned, as the arrow could confuse the            user into thinking that the APEX is at a certain point            within the vertebral body height, as opposed to simply            identifying the vertebral body in which the apex occurs.]        -   Additional data elements positioned underneath the “Lordosis            Type X (Roussouly)” label described above: “Total L1-S1            Lordosis=X°”, “Upper Lumbar Arc=Y°”, and “Lower Lumbar            Arc=Z°”    -   FIGS. 9A-B for the Rothenfluh and Roussouly versions of the        Sagittal Alignment Diagram:

Main Screen, Left Pane: Disc Space View

-   -   The Disc space view corresponds to the [ACTIVE LEVEL] level        (i.e. it presents data about the [ACTIVE LEVEL]    -   On the left hand pane of the widow: there can be four        sub-panels: (1) An upper left sub-panel (for the disc space        diagram), (2) an upper right sub-panel (for the Distance From/To        diagram), (3) a middle sub-panel (for the data table sub-panel),        and (4) a lower sub-panel (for overlays/options.        -   In the upper left sub-panel, which is for the Disc Space            Diagram, there can be:            -   A title label “Disc Space View”            -   A check box that makes the Disc Space Diagram visible                and un-visible (respectively). This comes defaulted to                visible.            -   The Disc Space Diagram (the features for the Disc Space                Diagram are given below in a separate dedicated                sub-section below)        -   In the upper right sub-panel, which is for the Distance            From/To Diagram, there can be:            -   There can be:                -   A label that says “Distance From [DROP DOWN 1] to                    [DROP DOWN 2]”                -    [DROP DOWN 1] system can:                -    Allow users to select from the list:                -    Current Capture: If [CAPTURE STATUS] is not “No                    Capture Yet”, else this is ghosted                -    Reference View (may be visible)                -    Target Construct: if [ACTIVE LEVEL] is selected for                    fusion, otherwise this is ghosted/inactive.                -    Prior Captures: if [CAPTURE STATUS] is “Current                    Capture with Prior captures”,                -    THEN there is a prior captures section, with the                    header “Prior Captures”, along with a list of prior                    captures, as specified in the Status Variable                    Features Section (see the end of the [REFERENCE                    VIEW] section)                -    ELSE there is only the label “Prior Captures” that                    is ghosted/inactive                -    If an line item is selected on [DROP DOWN 2], then                    that line item is ghosted on [DROP DOWN 1] (and vice                    versa)                -    Be defaulted to:                -    “Current Capture” in the case that the [CAPTURE                    STATUS] is not “No Capture Yet”                -    ELSE “Reference View”                -    [DROP DOWN 2] can have the same rules as [DROP DOWN                    1], except for:                -    Allows users to select from the list:                -    All items the same as for [DROP DOWN 1], except                    that the value (null) can be allowed in [DROP DOWN                    2].                -    Default values can be:                -    “Target Construct” in the case that the if [ACTIVE                    LEVEL] is selected for fusion                -    ELSE null                -   A checkbox next to the above-described label, such                    that checking and unchecking the check box makes the                    Distance From/To diagram object visible and                    un-visible (respectively). This comes defaulted to                    visible.                -   The Distance From/To Diagram (the features for the                    Distance From/To Diagram are given below in a                    separate dedicated sub-section below)        -   In the middle sub-panel, which is for the data table, there            can be:            -   A Label that says “Dimensions”            -   A drop down box with a label saying “Linear Dimension                Units”, with a drop down box that is defaulted to the                user configured default, and which can assume the values                of millimeters, % Vertebral Body Depth, % Max Range.            -   The following columns: Posterior Disc Height, Midline                Disc Height, Anterior Disc Height, Segmental Lordosis,                PI-LL                -   On the PI-LL column, if there are PI-LL alerts that                    have been activated, a yellow or red (as                    appropriate) alert icon can be displayed next to the                    appropriate number.            -   There can be a row for Target Construct, Current                Capture, and Reference View, so long as the respective                check box in the “Overlays” section is selected. In the                case that the checkbox is not selected, then the row                system cannot appear, and the table will be shorter.                -   In the case of Reference View, row heading can be                    “Ref. View: [VIEW TEXT]”. See the Status Variable                    features section for more information about the                    Reference View variable.        -   In the bottom sub-panel, which is for the Overlays and            Options, there can be:            -   A Label that says “OVERLAYS”            -   Underneath the “OVERLAYS” label, checkboxes and icons                for: Target Construct, Current Capture, Reference View,                Mobility Ranges, and Gravity (plumb).                -   For Target Construct, it can be ghosted/inactive if                    [ACTIVE LEVEL] is NOT selected for fusion.                -   For the Current Capture row, there can be two                    configurations:                -    If [CAPTURE STATUS]=“Current Capture with no prior                    captures”, then there can be a label saying “Current                    Capture” (not a drop down).                -    If [CAPTURE STATUS]=“Current Capture with prior                    captures”, then there can be a drop down, defaulted                    to the Current Capture, which draws from the list                    comprised of the Current Capture plus the Prior                    Captures, as described in the Status Variables                    Section of this document (see the end of the                    Reference View part of that).                -    If [CAPTURE STATUS]=“No capture yet”, the row                    (including the label, icon, and checkbox) can be                    ghosted.                -   For the Reference View row, there can be a drop down                    underneath which has a drop down box that allows the                    user to select among the [REFERENCE VIEW] values                    (See section about the Reference View in the Status                    Variable features section of this document for more                    details about these potential values)            -   A Label that says “OPTIONS”            -   Underneath the “OPTIONS” label:                -   A checkbox that says “Images” such that checking and                    unchecking the check box makes the image underlays                    visible and invisible (respectively).                -    Indented from the checkbox above, a set of three                    radio buttons with the labels “Target Construct”,                    “Current Capture”, and “Reference View”, defaulted                    to the value specified in user config, such that the                    specific image view is switched when the radio                    button values change.                -    Items in the set of three radio buttons (“Target                    Construct”, “Current Capture”, and “Reference View”)                    are ghosted/inactive if the corresponding checkbox                    in the “OVERLAYS” section is deselected, and become                    active when the corresponding checkbox is selected                -   A checkbox that says “Labels”            -   Checkbox, radio button, and drop down default values can                be set as configured in the user configuration                variables. Once a user selects/deselects checkboxes and                radio buttons or changes the value in dropdowns in this                section, those values system can persist if the user                should go to view another level's disc space view, or if                the user goes to another screen and then returns.    -   The Disc Space Diagram can be a diagram that, when activated for        display, will occupy the upper left sub-panel of the left pane        of the Disc Space View screen, and system can contain:        -   A target construct outlined in blue that is selectably            visible (based on the checkbox value):            -   A target construct, inferior vertebral body, positioned                such that the superior edge aligns with the horizon, and                that incorporates are “balls” at each of the superior                anterior and superior posterior corners.            -   A target construct, superior vertebral body, that                incorporates are “balls” at each of the inferior                anterior and inferior posterior corners                -   The target construct, superior vertebral body object                    described above system can only be visible if the                    [ACTIVE LEVEL] is selected for fusion. In all other                    cases, the object is invisible.        -   A capture outlined in red, that is selectively visible            (based on the checkbox value):            -   A capture, superior vertebral body            -   If [CAPTURE STATUS] is equal to “No Capture Yet” the                current capture, superior vertebral body system cannot                be displayed.            -   If the user has selected a prior capture from “OVERLAYS”                Section, the box should be red, but a different hue that                is darker (as compared to red used for the current                capture)        -   A reference view outlined in green, that is selectively            visible (based on the checkbox value):            -   A reference view, superior vertebral body        -   A set of min/max mobility range graphic elements that are            selectably visible (based on the checkbox value)            -   A posterior mobility range graphic element, which is:                -   a vertical element that has a background line that                    goes through the superior posterior corner of the                    target construct, inferior vertebral body, and also                    has a vertically oriented elongated rectangle (the                    long axis superimposed on the background line) that                    is sized to represent the min/max mobility range of                    the posterior disc height (PDH).                -    This element stays fixed in space if/when the user                    moves or rotates the target construct, superior                    vertebral body.                -   A horizontal background line that goes through the                    inferior posterior corner of the target construct,                    superior vertebral body, which meets the vertical                    element, and then becomes an arrow (on the other                    side of the vertical element) pointing to the                    vertical element.                -    This element moves along with the target construct                    if/when moves or rotates the target construct,                    superior vertebral body.            -   A vertical anterior mobility range graphic element,                which is                -   a vertical element that has a background line that                    goes through the superior anterior corner of the                    target construct, inferior vertebral body, and also                    has a vertically oriented elongated rectangle (the                    long axis superimposed on the background line) that                    is sized to represent the min/max mobility range of                    the anterior disc height (ADH).                -    This element stays fixed in space if/when the user                    moves or rotates the target construct, superior                    vertebral body.                -   A horizontal background line that goes through the                    inferior anterior corner of the target construct,                    superior vertebral body, which meets the vertical                    element, and then becomes an arrow (on the other                    side of the vertical element) pointing to the                    vertical element.                -    This element moves along with the target construct                    if/when moves or rotates the target construct,                    superior vertebral body.            -   A horizontal offset mobility range graphic element,                which is:                -   a horizontal element that has a background line that                    goes through the superior posterior corner of the                    target construct, inferior vertebral body, and also                    has a horizontally oriented elongated rectangle (the                    long axis superimposed on the background line) that                    is sized to represent the min/max mobility range of                    the offset.                -    This element stays fixed in space if/when the user                    moves or rotates the target construct, superior                    vertebral body.                -   A vertical background line that goes through the                    inferior posterior corner of the target construct,                    superior vertebral body, which meets the horizontal                    element, and then becomes an arrow (on the other                    side of the horizontal element) pointing to the                    horizontal element.                -    This element moves along with the target construct                    if/when moves or rotates the target construct,                    superior vertebral body.        -   A plumb line gravity indicator arrow that is selectively            visible (based on the checkbox value), with an arrow            endpoint that is co-located with the midpoint of the            inferior edge of the target construct, superior vertebral            body.        -   Background images (underlays) that are selectively visible            (based on the checkbox value). User can select to have            background images underlays be visible or invisible.            -   Users can further can specify to select from a set of                three radio buttons with labels “Target Construct”,                “Current Capture”, and “Reference Views”.                -   If [CAPTURE STATUS]=“No Capture Yet”, then the                    “Current Capture” can be ghosted/inactive.                -   If the [ACTIVE LEVEL] is not selected for fusion,                    then the “Target Construct” is ghosted/inactive            -   If Reference View or Current Capture are selected, the                appropriate image is displayed. These Images (all                reference views and the current capture) can have been                cropped to the [ACTIVE LEVEL]:                -   Find the leftmost, rightmost, topmost, and bottom                    most coordinates from the 8 points (4 for superior                    vertebral body, 4 for inferior vertebral body.                -   Extend 10% in each direction. [Note: This is a                    guess. This needs to be played with a bit to see                    what looks the best.]                -   Crop a square region around the two vertebral                    bodies, oriented to align the superior edge of the                    target construct, inferior vertebral body. (note1:                    If it is not too processor intensive, smooth/fade                    the borders. Note2: the cropped regions should be                    the same across views in terms of the cropping                    relative to the inferior vertebral body of a level,                    so that switching the image to view does not change                    the shape of the image underlay)            -   In the case the user has selected Target Construct, a                view is rendered:                -   Use as a base image the cropped standing neutral                    uncontrolled view. In the case that a current                    capture has occurred, use as a base image the                    cropped current capture image.                -   Cut the image along the inferior edge of the                    superior vertebral body.                -   Rotate and translate the upper section (above the                    cut) to position it where the target construct is                    positioned.                -    Allow the upper section to overwrite the lower                    section of the images.                -    If new space is created, that space can be filled                    with pixels colored to the average color across the                    image.                -    Re-Apply the cropping parameters            -   In the case the [ACTIVE LEVEL] is newly selected for                fusion surgery AND from the User Config the default                image is set to “Target Construct”, then switch the                image being viewed to Target Construct (and update the                radio button) from whatever its current value is.            -   In the case the status variable [CAPTURE STATUS] changes                from “No Capture Yet” to any other value AND from the                User Config the default image is set to “Current                Capture”, then switch the image being viewed to Current                Capture (and update the radio button) from whatever its                current value is.        -   The following actions can be available to the user when            moving the mouse over specific regions of the Disc Space            Diagram:            -   The Target Construct, Superior vertebral body can be                able to be grabbed and moved/rotated:                -   Grab/Drag the inferior edge of the target construct,                    superior vertebral body, and the user can be allowed                    to translate the target construct, superior                    vertebral body up/down and left/right.                -   Grab/Rotate the “balls” of the inferior edge of the                    target construct, superior vertebral body, and the                    user can be able to change the angle of the target                    construct.                -   Max range of motion allowed for Grab/Drag and                    Grab/Rotate actions: All points of the target                    construct, superior vertebral body system can stay                    within a rectangle with horizontal edges parallel to                    the superior edge of the target construct, inferior                    vertebral body, defined by:                -    Left/right: Max of [leftmost/rightmost points                    (among the 8 points for each view) across all                    Reference views, extending 10% beyond in each                    direction] OR 50% of vertebral body depth on either                    side                -    Up: 200% of Inferior vertebral body midline height                    above the horizontal superior edge of the Target                    Construct, inferior vertebral body.                -    Down: Minimum of the cropped regions across all                    Reference Views                -   In the case that: (1) image underlays are selected                    to be visible, and (2) the target construct is                    selected as the view to display;                -    then upon any update to the position/angle of the                    target construct, superior vertebral body, the                    target construct view needs to be re-rendered based                    on the updated location/angle.                -    This update also system can occur whenever the                    target construct geometry is updated by any other                    mechanism (see Calculation Features for all of the                    situations in which the target construct geometry is                    changed).                -   In the case that the Distance From/To diagram is                    visible, then upon any update to the position/angle                    of the target construct, superior vertebral body,                    the Distance From/To Diagram view needs to be                    re-rendered based on the updated location/angle.            -   Click the Plumb line gravity indicator arrow, and the                Disc Space Diagram can be rotated such that the plumb                line aligns with the vertical axis of the screen.                Clicking the plumb line again will re-orient the Disc                Space Diagram such that the target construct, inferior                vertebral body's superior edge is parallel to the                horizontal axis of the screen.    -   The Distance From/To Diagram can be a diagram that, when        activated for display, will occupy the upper right sub-panel of        the left pane of the Disc Space View screen, and system can        contain:        -   Three boxes can be displayed: The “from” construct, inferior            vertebral body; the “from” construct, superior vertebral            body, and the “to” construct, superior vertebral body            (filled in and on top of the other boxes)            -   These boxes can be vertically positioned such that they                align with the Disc space View graph to the left.            -   Each box system can assume the appropriate color as                already defined (blue=target, red=current capture,                green=reference). For a prior capture, the box should be                red, but a different hue that is darker (as compared to                red used for the current capture).        -   In the case that [DROP DOWN 2] is NOT null, then three red            arrow objects (and associated text and alert icons) can be            placed on the diagram, relative to box associated with the            “from” construct, superior vertebral body.            -   Each of the arrows can be sized commensurate with the                associated value            -   Each associated value can be displayed near the arrow in                the format “# # mm”            -   There can be:                -   A posterior height arrow                -    In the case that the value is an upward (positive)                    or zero value, the arrow can be positioned relative                    to the posterior inferior corner of the current                    capture box.                -    In the case that the value is a downward (negative                    value), the arrow can be positioned relative to the                    posterior superior corner of the current capture                    box.                -    In the case that an alert SP or PSO (or both) is                    active, there can be the appropriate alert icon                    displayed next to the value text associated with the                    posterior height arrow.                -   An anterior height arrow                -    In the case that the value is an upward (positive)                    or zero value, the arrow can be positioned relative                    to the anterior inferior corner of the current                    capture box.                -    In the case that the value is a downward (negative                    value), the arrow can be positioned relative to the                    anterior superior corner of the current capture box.                -    In the case that an ALL alert is active, there can                    be the appropriate alert icon displayed next to the                    value text associated with the anterior height                    arrow.                -   An offset arrow                -    In the case that the value is a rightward                    (positive) or zero value, the arrow can be                    positioned relative to the posterior inferior corner                    of the current capture box.                -    In the case that the value is a leftward (negative                    value), the arrow can be positioned relative to the                    anterior inferior corner of the current capture box.        -   A rotation indicator icon along with a text label showing            the additional lordosis            -   The additional lordosis value can be displayed near the                icon in the format “+#°” or “−#°” as appropriate based                on the value.            -   The icon can be a counterclockwise rotation icon in the                case that the additional lordosis value is positive or                zero.            -   The icon can be a clockwise rotation icon in the case                that the additional lordosis value is negative.

Main Screen, Left Pane: View Lumbar Images

-   -   There can be a title label: “Reference View”, with a drop down        box referencing the REFERENCE VIEW variable.    -   There can be a space on the page for the image to reside in its        native format (Optimized for 1 k×1 k pixels, but able to accept        up to 2 k×1.5 k).    -   There can be a gravity Indicator, comprising an arrow and a        label “Gravity” next to the image, that is selectably visible        (based on the checkbox), but also that system can only be        visible if the [REFERENCE VIEW] has gravity data (otherwise this        object is invisible).    -   Underneath the image, there can be the following user input        sections:        -   A column title label “ORIENTATION”, under which is a set of            radio buttons corresponding to the labels “Gravity”, “Most            Recent Capture”, “Native” or “LX Superior Edge”            -   “LX” can be the vertebral body label corresponding to                the ACTIVE LEVEL.            -   The “LX Superior Edge” item (Label+radio button) can be                invisible and inactive if there is ACTIVE LEVEL=null.            -   The “Most Recent Capture” item (Label+radio button) can                be inactive/ghosted if the [CAPTURE STATUS]=“No Capture                Yet”            -   The “Gravity” item (Label+radio button) be                inactive/ghosted if the [REFERENCE VIEW] does NOT                contain gravity data            -   This set of radio buttons can be defaulted based on data                from user config, and whenever a new value is selected,                the image and the gravity indicator get rotated as                appropriate.        -   A column title label “SELECT VIEW”, under which is a set of            radio buttons corresponding to the labels “LX-LY”, “LY-LZ”,            or “Pelvic View”            -   The two elements “LX-LY” and “LY-LZ” appear in this list                only if there are both superior and inferior views                associated with a specific REFERENCE VIEW. If there is                only one view that contains L1-S1, then there will only                be one label “L1-S1”.            -   The “Pelvic View” item will only appear if REFERENCE                VIEW=Standing uncontrolled neutral.            -   This section (the column titled “SELECT VIEW”) can be                invisible if there is only one item (i.e. “L1-S1”,                meaning no superior/inferior views and no pelvic view).        -   A column title label “OPTIONS”, under which is a set of            check boxes corresponding to the labels            -   “Gravity”, “Labels” and “Templates”                Selecting/Deselecting the “Gravity” checkbox makes the                gravity indicator described above toggle between                visible/invisible (respectively).                -   The “Gravity” item (Label+checkbox) be                    inactive/ghosted if the [REFERENCE VIEW] does NOT                    have gravity data            -   Selecting/Deselecting “Labels” makes the vertebral body                label overlays on the image toggle between                visible/invisible (respectively).            -   Selecting/Deselecting “Templates” makes the vertebral                body template overlays on the image toggle between                visible/invisible (respectively).                -   Templates get created via a function that creates                    corner and cross hairs line coordinates, provided a                    4 (x,y) vertebral body position corner points. [This                    function can be achieved using Matlab from                    MathWorks® However, other languages can be used                    without departing from the scope of the                    disclosure.].

Capture Screen

-   -   The Capture Screen can be substantially the same as the Main        Screen. Whereas the Main Page has three variants on the left        pane and two on the right pane, the Capture Screen represents a        variant of the left and right pane can be displayed together.    -   The left pane system can: Contain the following page elements:        -   A title label “Fluoro View”        -   Underneath title, there can be set of five radio buttons,            with labels “L1/L2” . . . “L5/S1”, arranged in a row, with            that row header labeled “Level to Capture”, and which are            linked to the value of [MARKUP LEVEL]            -   This can be defaulted to [ACTIVE LEVEL], and can be                changeable by the user.            -   In the case that [ACTIVE LEVEL]=null, then this row of                radio buttons is active, but none are selected.        -   There can be an Image Section wherein image system can            reside in its native format (Optimized for 1 k×1 k pixels,            but able to accept up to 2 k×1.5 k).        -   There can be a set of labels and radio buttons, this set of            labels and radio buttons being labeled “VIEW:”            -   “Live Fluoro Feed”, when selected, system can show in                the image space the live fluoro feed coming from the                image capture system.            -   “Live Fluoro Feed” is the default value. Until a capture                has occurred, this set of radio buttons can only have                the value “Live Fluoro Feed”            -   “Current Capture”, when selected, system can show the                image stored as the current capture.                -   If [MARKUP STATUS] is equal to Step 0 to Step 4                    (i.e. not step 5), then the previously marked up                    corners can be visible on the image, and available                    for editing by the user.            -   In the case that a [CAPTURE STATUS] is set to “Current                Capture with Prior captures”, then there system can also                be the item “Prior Capture” visible, which can be                positioned next to a drop down list populated by a list                of the prior captures. The specific features for the                list of prior captures for the drop down list can be                found in the section about the status variables                [REFERENCE VIEW] and [COMPARE PRIOR MARKUP VIEW] from                the Status Variable Features Section of this document.        -   A Button that says “Grab Frame”, that can be active only            when the set of radio buttons above is set to “Live Fluoro            Feed”. When this button is pressed:            -   The image Section changes from a video feed to a freeze                frame of the image that is potentially going to be                saved.            -   A check is done on the status variable [CALIBRATE                STATUS].                -   If FALSE, then a pop-up can be displayed to the                    user.                -    The label can be displayed: “To proceed with this                    image capture, a Grid calibration image can be                    captured as well, which has not occurred yet. Press                    “OK” to capture the calibration image right now.                    Press “Cancel” to cancel the current video capture                    action and lose the image data that is presently                    displayed”                -    There can be an OK and cancel button.                -    Pressing OK system can pull up the Calibrate Modal                    Window.                -    Pressing Cancel system can: (1) close the                    pop-up, (2) resume the live video feed in the Image                    Section, and (3) return the user to the Capture                    Screen                -   If TRUE the take no action            -   An instance of the [CAPTURE DATA] dataset can be                created, and the current live fluoro feed image gets                saved as the image within that dataset            -   The correction matrix can be accessed from the                [CALIBRATE DATA] data structure, and then can be used to                reseal the image to correct for distortion.            -   the radio button can be changed to “Current Capture”                from “Live Fluoro Feed” the “Grab Frame” images can                become ghosted and inactive.            -   The right pane system can contain:        -   A Title at the top “STATUS: [Status Text]”. [Status Text]=            -   “Capture and markup complete” In the case that [MARKUP                STATUS]=Step 5 and [MARKUP SAVE SATUS]=“Saved”            -   “Markup in process” In the case that [MARKUP                STATUS]=Step 1 to Step 4            -   “Need to Save or Cancel Changes” In the case that                [MARKUP STATUS]=Step 5 and [MARKUP SAVE SATUS]=“Unsaved”            -   “Needs markup (capture complete)” In the case that                [MARKUP STATUS]=Step 0        -   An Area for Directions, which is visible only when the            [Status Text]=“Needs markup (capture complete).” Or “markup            in process”            -   A Text Box Labeled “Markup Directions” in which                Direction text is displayed.            -   A Markup Diagram, which can assume one of five                configurations                -   For steps 1, 2, 4, and 5, the Markup Diagram assumes                    the form shown in FIGS. 12                    (green items are instructions, not part of the                    diagram).                -    The red dot is placed at the appropriate corner                    (Step 1=POST/INF, Step 2=ANT/INF, Step 4=POST/SUP,                    Step 5=ANT/SUP)                -    In the boxes, the text label system can say “SUP.”                    and “INF” if [MARKUP LEVEL]=“Unspecified”.                    Otherwise, they say “LY” and “LX” respectively,                    where “LY” is the label of the superior vertebral                    body of the level and “LX” is the label of the                    inferior vertebral body of the level. See, FIG. 10.                -   For step 3, the Markup Diagram can be a row of 6                    radio buttons, with labels: L1, L2, L3, L4, L5,                    S1.).        -   A set of buttons “Cancel” and “Save”, which can be active            whenever [MARKUP SAVE STATUS] is set to “Unsaved”            -   Upon Pressing “Save”, the [MARKUP POINTS], [MARKUP                LEVEL] can be saved and the [MARKUP SAVE STATUS] can be                set to “SAVED”            -   Upon Pressing “Cancel”, none of the changes that have                been made to data since arriving at the “Capture” screen                can be saved.            -   Upon pressing either, active control can be switched                from Capture Screen back to Main Screen.        -   A Compare to Prior Spine Markup Area, which can be visible            whenever the [MARKUP LEVEL] is not “Unspecified”            -   In the user configuration, a default value is assigned                for default view for Compare to Prior Spine Markup.                There can be a label “Compare to Prior Spine Markup”,                next to a drop down box that allows the user to change                the value the variable [COMPARE PRIOR MARKUP VIEW]. See                the Status Variable Features for more details about this                variable.            -   The specified image can be accessed, and can be cropped                to the Level specified by [MARKUP LEVEL] according to                the cropping features provided in the “Main Screen, Left                Pane: Disc Space View” Section of this document.            -   The cropped view can be displayed, with the four                fiducials associated with the levels placed on top.                -   In the case that [MARKUP STATUS] is less than Step 3                    or higher, the view can be displayed such that the                    view is rotated to align the Inferior edge of the                    disc space with the current capture.                -   Else, the view can be displayed in its native                    orientation.    -   In the case that the “VIEW:” radio buttons are set to “Current        Capture” OR “Prior capture”, AND the associated [MARKUP        STATUS]=Step 0 through Step 4; then        -   On the left pane the 7 tabs at the top, and on the right            pane the other two tabs at the top (“Surgery Summary” and            “Level Summary”) system can all be ghosted/inactive        -   The Image Section of the Capture screen system can:            -   Display fiducial markers on the images. Fiducial markers                are objects placed in the field of view as a point of                reference. The number and composition of the fiducials                can be based on the [MARKUP STATUS] variable:                -   Step 1: 1_INF_VERT_POST_SUP_CORNER                -   Step 2: Add 2_INF_VERT_ANT_SUP_CORNER, and create a                    line with that as an endpoint and the other one at                    2_INF_VERT_ANT_SUP_CORNER                -   Step 3: Add 3_SUP_VERT_POST_INF_CORNER                -   Step 4: Add 4_SUP_VERT_ANT_INF_CORNER, and create a                    line with that as an endpoint and the other one at                    3_SUP_VERT_POST_INF_CORNER            -   Highlight a previously-placed fiducial as a user moves                the mouse over it, allowing the following actions upon a                click:                -   Enable the user to edit the location of the                    fiducials on the image by click/Dragging them. As                    they are click/dragged, if there is a line                    connecting a fiducial to another fiducial, the line                    length/angle changes as the other fiducial stays                    fixed                -   Enable the user to edit the location of lines that                    connect the fiducials by click/dragging them. As                    they are click/dragged, the line and both endpoints                    move in lock step.        -   The user can be initiated into a workflow that progresses            from a starting point defined by the current [MARKUP            STATUS], and that terminates upon the user clicking “SAVE”,            or “CANCEL”            -   Step 0:                -   Configuration of the Area for Directions                -    Direction text:                -    If [MARKUP LEVEL] is set to a level (i.e. not                    “unspecified”): “Mark the posterior corner of [LX]”.                    “LX”=the label of the inferior vertebral body of                    [MARKUP LEVEL]                -    If [MARKUP LEVEL] is “Unspecified”: “Mark the                    Posterior corner of the inferior vertebral body”                -    Markup Diagram description: Red dot at POST/INF                    corner of disc space            -   Step 1: [MARKUP STATUS] system can increment from Step 0                to Step 1 when the user selects a point on the Image                Section of the Capture Page.                -   [MARKUP POINT] can be saved                    (1_INF_VERT_POST_SUP_CORNER)                -   [MARKUP SAVE STATUS] can be set to “Unsaved”                -   A line can be created, with an endpoint at                    (1_INF_VERT_POST_SUP_CORNER) and with another                    endpoint at the current cursor location. As the user                    moves the mouse, the line changes in angle and                    length, and if the user moves mouse off the Image                    the line stops at the edge of the image but goes in                    a direction where the mouse is.                -   Configuration of the Area for Directions                -    Direction text:                -    If [MARKUP LEVEL] is set to a level (i.e. not                    “unspecified”): “Mark the anterior corner of [LX]”.                    “LX”=the label of the inferior vertebral body of                    [MARKUP LEVEL]                -    If [MARKUP LEVEL] is “Unspecified”: “Mark the                    anterior corner of the inferior vertebral body”                -    Markup Diagram description: Red dot at ANT/INF                    corner of disc space            -   Step 2-3: [MARKUP STATUS] system can increment from Step                1 to Step 2 when the user selects a point on the Image                Section of the Capture Page.                -   [MARKUP POINT] can be saved                    (2_INF_VERT_ANT_SUP_CORNER)                -   A line can be placed, with endpoints at                    (1_INF_VERT_POST_SUP_CORNER) and                    (2_INF_VERT_ANT_SUP_CORNER).                -   The cursor system can resume normal functions.                -   [MARKUP SAVE STATUS] can be set to “Unsaved”                -   In the case that If [MARKUP LEVEL] is set to a level                    (i.e. not “unspecified”):                -    An additional step is added:                -    Direction text: “Label the inferior vertebral body”                -    Markup Diagram description: Display a row of 6                    radio buttons, with labels: L1, L2, L3, L4, L5, S1.                -    Selecting a radio button here                -    sets the [MARKUP LEVEL] to the appropriate level                -    The radio buttons at the top of the left pane of                    the Capture window, which are synchronized to the                    [MARKUP LEVEL] Variable, can be updated as                    appropriate.                -    Upon either selecting a radio button here                    associated with the inferior vertebral body of a                    level, or selecting a level from the radio buttons                    at the top of the left pane of the Capture window,                    the [MARKUP STATUS] system can increment from Step 2                    to Step 3                -    Else ([MARKUP LEVEL] is NOT “Unspecified”), [MARKUP                    STATUS] System can increment from Step 2 to Step 3            -   Step 3: Configuration of the Area for Directions                -   Direction text: “Mark the posterior corner of [LY]”.                    “LY”=the label of the superior vertebral body of                    [MARKUP LEVEL]                -   Markup Diagram description: Red dot at POST/SUP                    corner of disc space            -   Step 4: [MARKUP STATUS] system can increment from Step 3                to Step 4 when the user selects a point on the Image                Section of the Capture Page.                -   [MARKUP POINT] can be saved                    (3_SUP_VERT_POST_INF_CORNE)                -   A line can be created, with an endpoint at                    (3_SUP_VERT_POST_INF_CORNE) and with another                    endpoint at the current cursor location. As the user                    moves the mouse, the line changes in angle and                    length, and if the user moves mouse off the Image                    the line stops at the edge of the image but goes in                    a direction where the mouse is.                -   [MARKUP SAVE STATUS] can be set to “Unsaved”                -   Configuration of the Area for Directions                -    Direction text: “Mark the anterior corner of [LY]”.                    “LY”=the label of the superior vertebral body of                    [MARKUP LEVEL]                -    Markup Diagram description: Red dot at ANT/SUP                    corner of disc space            -   Step 5: [MARKUP STATUS] system can increment from Step 4                to Step 5 when the user selects a point on the Image                Section of the Capture Page.                -   [MARKUP POINT] can be saved                    (4_SUP_VERT_ANT_INF_CORNER)                -   A line can be placed, with endpoints at                    (3_SUP_VERT_POST_INF_CORNER) and                    (4_SUP_VERT_ANT_INF_CORNER).                -   The cursor system can resume normal functions.                -   [MARKUP SAVE STATUS] can be set to “Unsaved”                -   Once the above actions have occurred, the user can                    either press “Save” or “Cancel” (or “Exit” or “Load                    Patient”) to progress.    -   In the case that the “VIEW:” radio buttons are set to “Current        Capture” OR “Prior capture” and the associated [MARKUP        STATUS]=Step 5        -   The Image Section of the Capture screen system can:            -   Display fiducials on the images. The number and                composition of which can be based on the [MARKUP STATUS]                variable:                -   Step 1: 1_INF_VERT_POST_SUP_CORNER                -   Step 2: Add 2_INF_VERT_ANT_SUP_CORNER, and create a                    line with that as an endpoint and the other one at                    2_INF_VERT_ANT_SUP_CORNER                -   Step 3: Add 3_SUP_VERT_POST_INF_CORNER                -   Step 4: Add 4_SUP_VERT_ANT_INF_CORNER, and create a                    line with that as an endpoint and the other one at                    3_SUP_VERT_POST_INF_CORNER            -   Highlight a previously-placed fiducial whenever a user                moves the mouse over it, allowing the following actions                upon a click:                -   Enable the user to edit the location of the                    fiducials on the image by click/Dragging them. As                    they are click/dragged, if there is a line                    connecting a fiducial to another fiducial, the line                    length/angle changes as the other fiducial stays                    fixed                -   Enable the user to edit the location of lines that                    connect the fiducials by click/dragging them. As                    they are click/dragged, the line and both endpoints                    move in lock step.        -   Whenever any of the [MARKUP POINTS] are changed by the user            making edits to the location of fiducials overlaid on the            image, the [MARKUP SAVE STATUS] is set to “Unsaved”        -   In the case that [MARKUP SAVE STATUS] is set to “UNSAVED”            -   On the left pane the 7 tabs at the top, and on the right                pane the other two tabs at the top (“Surgery Summary”                and “Level Summary”) system can all be ghosted/inactive.            -   The user can either press “Save” or “Cancel” (or “Exit”                or “Load Patient”) to progress.

Modal Windows (Accessible Via the Main Screen and Capture Screen)

-   -   Modal windows can be accessible via the Main Screen and Capture        Screen.        -   There can be the following modal windows:            -   Load New Patient            -   Load Previous Session            -   Edit Midline Disc Height (A1)            -   Edit Offset (A2)            -   Edit Lordosis (A3)            -   Lordosis Distribution Calculations (Routhenfluh) (B1)            -   Lordosis Distribution Calculations (Roussouly) (B2)            -   Edit Correction for Anticipated Subsidence (C1)            -   Calibrate (D)        -   The modal windows, when accessed, can be the only active            window, and the previous active window is greyed out,            unless/until the user either takes an action within the            window that closes it or the user clicks on a greyed out            portion of the previous active window, both of which have            the effect of closing the modal window.    -   Load New Patient        -   There can be a title “Load a new patient to start a session”        -   There can be a button “Re-Open Previous Session” which, when            pressed, system can close the Load New Patient modal window            and open the Load Previous Session modal window.        -   There can be a means for the user to select a patient file            for loading from a removable media            -   The list of files to select from system can include                FIRST NAME/LAST NAME initial and date of birth (DOB)            -   List items can be sorted with newest first            -   Pressing Select system can initiate a load of that                patient file.                -   The system can copy files                -   The system can decrypt the files                -   The system can initialize a user session based on                    the contents of the files                -   The system can present a status window (See Load New                    Patient—SUBWINDOW2) to the user to inform the user                    of the status of the process of initializing the                    user session. This window system can also allow the                    user to cancel the load, which returns the user to                    the Load New Patient modal window                -   Once loaded and initialized, the user can be                    returned to the Main Screen.                -   If possible, the system can,                -    prior to initiating a potentially lengthy load and                    initialization cycle, first read and decrypt the                    patient's full name, DOB, and study date,                -    Present said data to the user in a pop-up (See Load                    New Patient—SUBWINDOW1) wherein the user confirms or                    cancels the load operation.                -    If user confirms the patient data, the:                -    a check is done on the user type, and for OR ADMIN                    user types:                -    a list of surgeons pops-up, and the OR Admin user                    selects the surgeon who is running the case from the                    list of all SURGEON users on the system.                -    Once this gets set, a check is done to see if the                    Surgeon's user has ever been through the                    click-through agreement in the User Configuration                    pages.                -    If so, no action.                -    If not, the user is instructed to log off and have                    the surgeon user login and accept the configuration                    click through, and the patient is not loaded, active                    control goes back to the Load New Patient modal                    window.                -    active control goes to the initialization status                    window if still loading/initializing, or active                    control goes to the Main Screen if initialization                    process is complete.                -    If the user presses cancel, active control goes                    back to the Load New Patient modal window.                -    The more lengthy full load and initialization                    operations can begin once the pop-up has been popped                    up (i.e. while the user is being presented with                    SUBWINDOW1 and taking the time to react to it, the                    system in the background is completing the                    load/initialize operation).        -   There can be a “Cancel” Button, which system can close the            Load New Patient modal window and Return the user to the            Screen from which the user came.    -   Load Previous Session        -   There can be a title “Re-Open a Previous Session”        -   There can be a means for the user to select a patient file            for loading from a repository on the computers fixed media            (hard drive) that contains previously stored user sessions.            -   The list of files to select from system can include:                First name, Last Name, DOB, Date of Study, Date of prior                session            -   List items can be sorted with newest first (with respect                to the date of prior session)            -   The list of files to select from is determined by:                -   For SURGEON users, whether or not the site-level                    parameter is set that allows surgeons to view data                    from other surgeons at the same site.                -   For ADMIN users, all patients at a given site.            -   Pressing Select system can initiate a load of the                specified session files.                -   The system can initialize a user session based on                    the contents of the files such that it represented                    the last state of the user session data prior to the                    last exit action that closed it.                -   The system can present a status window (See Load New                    Patient—SUBWINDOW2) to the user to inform the user                    of the status of the process of initializing the                    user session. This window system can also allow the                    user to cancel the load, which returns the user to                    the Load Previous Session modal window                -   Once loaded and initialized, the user can be                    returned to the Main Screen.        -   There can be a “Cancel” Button, which system can close the            Load Previous Session modal window and Return the user to            the Screen from which the user came.    -   Edit Midline Disc Height (A1), Edit Offset (A2), Edit Lordosis        (A3)        -   Users can be able to access these pages in one of two ways:            -   There is a minimum number of levels needed to calculate                an average Disc Height, Offset, and Lordosis that is                part of the User configuration. Whenever the user                attempts to select a level for exclusion such that the                total number of level not selected for fusion goes below                this minimum, then this can be allowed, but this window                can be popped up.            -   If the user hits the “edit disc height”, “edit offset”,                or “edit lordosis” buttons        -   Edit Midline Disc Height (A1) and Edit Offset (A2) are            nearly identical, and are described in the same section            (with differences identified).            -   There can be a title “Edit Midline Disc Height” or “Edit                Offset”.            -   There can be instructions: “Adjust the [Midline Disc                Height/Offset] by selecting/deselecting levels for                exclusion, or by directly adjusting the value on the                edit box below. The column on the right allows each                level to be set separately.”            -   There can be a matrix of data and objects:                -   There can be five rows, one for each level “L1/L2”                    through “L5/S1”                -   There can be five columns”                -    A first column with header label “Excluded?”, and a                    column of checkboxes that are linked with the check                    boxes on the Surgery Summary Object (from the Main                    Screen)                -    A second column with                -    header label “MIDLINE DISC HEIGHT (from system)” in                    the case of Midline Disc Height (A1) window; header                    label “Offset (from the vertebral motion analysis)”                    in the case of Edit Offset (A2) window                -    a column of millimeter values (#.#)                -    A third column labeled “Data for Average                    Calculation” with the values from the previous                    column, excluding those that which are selected in                    the first column.                -    Underneath the third column, there can be an edit                    box with up/down increment buttons (#.# mm)                -    The value can be defaulted to the computed average                    (after exclusions).                -    Upon a user edit to the value in this edit box, all                    of the values in the edit boxes in the fifth column                    system can change to the new edited value.                -    To the left of that edit box, there can be the                    label “Average After Exclusions”.                -    Underneath the edit box and label above, there can                    be another row of data                -    There can be a label directly below the label                    “Average After Exclusions” that system can say                    “Computed value”                -    There can be the average value from that column                    displayed (# # mm), which is the average of the                    non-excluded values, directly below the edit box.                -    A fourth column with header label “Level Selected                    for Fusion?”, and a column of checkboxes that are                    linked with the check boxes on the Surgery Summary                    Object (from the Main Screen) and also in the tabs                    on the left side of the Main Page.                -    A fifth columns column with:                -    header label “MIDLINE DISC HEIGHT” for Midline Disc                    Height (A1) window; header label “Offset” for Edit                    Offset (A2) window                -    For those levels that are selected for fusion, a                    column of edit boxes with up/down increment buttons.                -    Each of the edit boxes can be independently                    editable, and when users make edits to any of these                    edit boxes, it has no effect on the value of the                    edit box underneath the third column.            -   There can be a “Restore Default” Button that can be                visible whenever the value of the Disc Height or Offset                status variable [CHECKBOX COLUMNS ACTIVE] is FALSE.                -   Clicking the restore default values will set all                    values back to the computed average value (after                    exclusions), and set the [CHECKBOX COLUMNS ACTIVE]                    to true.            -   There can be Save button, which system can save the                changes made since the modal window has been active,                then close the window and return control to the                referring page.            -   There can be Cancel button, which system can close the                window and return control to the referring page.            -   In the case that the current number of non-excluded                levels is below the minimum value specified in the User                Config:                -   Alert text system can appear, underneath the first                    column “Too many levels are excluded. Your minimum                    is at least X non-excluded levels. You can deselect                    a level to proceed.”                -   The Save button can be ghosted and inactive                -   If the user clicks “Cancel”, then all of the edits                    made since the modal window was popped up get                    undone.                -    In the case that the modal window had been popped                    up by the user's selection of a level for exclusion                    that resulted in the total number of non-excluded                    levels to go below the minimum value set in user                    config, the level that had been selected for                    exclusion to prompt the pop-up of the modal window                    is deselected.        -   Edit Lordosis (A3) is described below:            -   There can be a title “Edit Target Segmental Lordosis”.            -   There can be instructions: “The target segmental                lordosis calculations are Shown Below. The model can be                adjusted by adjusting the levels excluded from the                lordosis model.”            -   There can be a matrix of data and objects:                -   There can be five rows, one for each level “L1/L2”                    through “L5/S1”                -   There can be four columns on the left have of the                    window                -    A first column with header label “Excluded?”, and a                    column of checkboxes that are linked with the check                    boxes on the Surgery Summary Object (from the Main                    Screen)                -    A second column with header label “A. Segmental                    Lordosis (From vertebral motion analysis)” plus a                    column of degree values)(#°)                -    A third column with header label “B. DISTRIBUTION                    (from Config)” plus a column of percent values (#%).                    There can be a                -    A fourth column labeled “QUOTIENT: % PER DEGREE                    (Calc, AB)” with the values from the previous                    column, excluding those that are selected in the                    first column.                -    Underneath the fourth column, is the average of the                    column (#.#) after exclusions, with a label to the                    left that says “C. Average=”.                -    Above the four columns is a label “Step 1:                    Determine average degrees per percent contribution                    to lordosis for non-excluded levels”                -   There can be three columns on the right half of the                    window, such that the rows continue to align from                    the matrix of data                -    A first column with header label “Level Selected                    for Fusion?”, and a column of checkboxes that are                    linked with the check boxes on the Surgery Summary                    Object (from the Main Screen) and also in the tabs                    on the left side of the Main Page.                -    A second column with header label “D. TARGET                    LORDOSIS (calc, B*C)” and a column of degree                    values)(#°), which system can only contain values                    for those rows with a check in the checkbox in the                    “Level Selected for Fusion?” column of checkboxes.                -    A third column with header label “CHANGE FROM                    VERTEBRAL MOTION ANALYSIS (calc, D-A)” plus, for                    those levels that are selected for fusion, a column                    of degree change values (+#° or −#).                -    Underneath the third column is the sum of the                    column above given as a degree change value (+#° or                    −#°), with a label to the left that says “Sum=”                -    Above the three columns is a label “Step 2: For all                    levels selected for fusion, project target lordosis                    based on an adjusted distribution function.”            -   There can be Save button, which system can save the                changes made since the modal window has been active,                then close the window and return control to the                referring page            -   There can be Cancel button, which system can close the                window and return control to the referring page.            -   In the case that the current number of non-excluded                levels is below the minimum value specified in the User                Config:                -   Alert text system can appear, underneath the first                    column “Too many levels are excluded. Your minimum                    is at least X non-excluded levels. You can deselect                    a level to proceed.”                -   The Save button can be ghosted and inactive                -   If the user clicks “Cancel”, then all of the edits                    made since the modal window was popped up get                    undone.                -    In the case that the modal window had been popped                    up by the user's selection of a level for exclusion                    that resulted in the total number of non-excluded                    levels to go below the minimum value set in user                    config., the level that had been selected for                    exclusion to prompt the pop-up of the modal window                    is deselected.    -   Lordosis Distribution Calculations (Routhenfluh) (B1)        -   There can be a title “Calculations: Allocating additional            lordosis across levels”.        -   There can be instructions: “The total additional lordosis,            as well as the additional segmental lordosis by level, can            be directly adjusted.”        -   There can be a matrix of data and objects:            -   There can be five rows, one for each level “L1/L2”                through “L5/S1”            -   There can be four columns                -   A first column with header label “Level Selected for                    Fusion?”, and a column of checkboxes that are linked                    with the check boxes on the Surgery Summary Object                    (from the Main Screen) and also in the tabs on the                    left side of the Main Page.                -   A second column with header label “DISTRIBUTION                    (from Config)” plus a column of percent values (#%).                    Underneath this column there is a label “Σ≈100%”                    (note curvy equal sign).                -   A Third column with header label “A. DISTRIBUTION                    (Adjusted)” plus a column of percent values (#%),                    excluding values from rows that are not selected for                    fusion, and normalized such that the sum of all                    non-excluded levels can be 100%. Underneath this                    column there is a label “Σ=100%” (note normal equal                    sign), and under that label another label “The                    distribution function is adjusted so that the sum of                    levels selected for fusion is 100%.”                -   A Fourth column with header label “ADDITIONAL                    SEGMENTAL LORDOSIS (calc, A*B)” plus two                    sub-columns, with each sub-column only containing                    data for those levels that are selected for fusion:                -    the first with sub-column header label “Computed                    value” and a column of degree change values (+#° and                    −#°)                -    the second with sub-column header label                    “User-Edited Value” a column of Edit boxes with                    up/down increment buttons, defaulted to the computed                    value, and containing degree change values (+#° and                    −#°).                -    Changing the value of any of these edit boxes                    system can change the value of the edit box                    underneath the fourth column, second sub-column                -    Underneath the Fourth column:                -    There can be a degree change value (+#° and −#°)                    under the first sub-column of the fourth column that                    represents the sum of the values displayed in the                    columns above (which system cannot include the                    excluded levels).                -    To the left of that value there can be a label “B.                    ADDITIONAL LORDOSIS”                -    There can be an Edit box with up/down increment                    buttons, defaulted to the computed value, and                    containing degree change values (+#° and −#°) under                    the second sub-column of the fourth column.                -    Any change to the value of this edit box system                    can:                -    Change the values of the edit boxes in the fourth                    column, second sub-column                -    Change the “Additional Lordosis” value that is                    presented on the Surgery Summary object, and vice                    versa.        -   There can be Save button, which system can save the changes            made since the modal window has been active, then close the            window and return control to the referring page        -   There can be Cancel button, which system can undo all of            edits made since the modal window was popped up, then close            the window and return control to the referring page    -   Lordosis Distribution Calculations (Roussouly) (B2)        -   There can be a title “Calculations: Allocating additional            lordosis across levels”.        -   There can be instructions: “The total additional lordosis            for each of the upper and lower arcs, as well as the            additional segmental lordosis by level, can be directly            adjusted.”        -   There can be a matrix of data and objects:            -   There can be five rows, one for each level “L1/L2”                through “L5/S1”            -   There can be five columns                -   A first column with header label “Level Selected for                    Fusion?”, and a column of checkboxes that are linked                    with the check boxes on the Surgery Summary Object                    (from the Main Screen) and also in the tabs on the                    left side of the Main Page.                -   A second column with header label “DISTRIBUTION                    (from Config)” plus a column of percent values (#%).                    Around the column of data is a box with the label                    “Σ≈100%” (note curvy equal sign)                -   A third, fourth, and fifth columns, which all get                    split horizontally based on the location of the APEX                    of the lumbar curve (See Calculations Features                    section for more detail about the Apex calculation).                -    A Third column:                -    header label “A. DISTRIBUTION (Adjusted)”                -    a column of percent values (#%), excluding values                    from rows that are not selected for fusion.                -    Around each group of values (above and below the                    horizontal split), there is a box with the label                    “Σ=100%” (note normal equal sign)                -    Underneath the column is another label “The                    distribution function is adjusted so that the sum of                    levels selected for fusion within each of the upper                    and lower arcs is 100%.”                -    A Fourth column:                -    header label “B. ADDITIONAL LORDOSIS (input by                    user)”                -    In the vertical center of each section (above and                    below the horizontal split), an edit box with                    up/down increment button. In the upper area, the                    label above the edit box is “Upper Arc”. In the                    lower area, the label above the edit box is “Lower                    Arc”.                -    Any changes to the value in either of the edit                    boxes in this column system can:                -    change the value in the corresponding edit boxes in                    the fifth column (second sub-column)                -    change the value of the corresponding edit box                    (either Upper Arc or Lower Arc) on the Surgery                    Summary Object.                -    A Fifth column:                -    header label “ADDITIONAL SEGMENTAL LORDOSIS (calc,                    B*C)”                -    plus two sub-columns, with each sub-column only                    containing data for those levels that are selected                    for fusion:                -    the first with sub-column header label “Computed                    value” and a column of degree change values (+#° and                    −#°)                -    the second with sub-column header label                    “User-Edited Value” a column of Edit boxes with                    up/down increment buttons, defaulted to the computed                    value, and containing degree change values (+#° and                    −#°).                -    Changing the value in any of the edit boxes in this                    column system can change the value in the                    corresponding edit box(es) in the fourth column        -   There can be Save button, which system can save the changes            made since the modal window has been active, then close the            window and return control to the referring page        -   There can be Cancel button, which system can undo all of            edits made since the modal window was popped up, then close            the window and return control to the referring page    -   Edit Correction for Anticipated Subsidence (C1)        -   There can be a title “Edit Correction for Anticipated            Subsidence”.        -   There can be instructions: “The correction for anticipated            subsidence is a geometric calculation of the anticipated            lordosis loss that would occur given a specific amount of            millimeter lordosis and assumed implant length*. Change            either of these two parameters to alter the angle of require            correction to offset this subsidence, or vice versa.”        -   There can be a matrix of data and objects:            -   There can be five rows, one for each level “L1/L2”                through “L5/S1”            -   There can be six columns:                -   A first column with header label “Level Selected for                    Fusion?”, and a column of checkboxes that are linked                    with the check boxes on the Surgery Summary Object                    (from the Main Screen) and also in the tabs on the                    left side of the Main Page.                -   A second column with header label “A. LENGTH OF                    SUPERIOR EDGE OF INFERIOR VERTEBRAL BODY (from                    vertebral motion analysis)” plus a column of                    millimeter values (#.# mm), excluding values from                    rows that are not selected for fusion.                -   A third column:                -    header label “B. ASSUMED LENGTH OF IMPLANT”                -    plus two sub-columns, with each sub-column only                    containing data for those levels that are selected                    for fusion:                -    the first with sub-column header label “From User                    Config” and a column of millimeter values (# mm)                -    the second with sub-column header label                    “User-Edited Value” a column of Edit boxes with                    up/down increment buttons, defaulted to the value                    from User Config, and containing millimeter values                    (# mm)                -   A fourth column with header label “C. OFFSET (from                    vertebral motion analysis)” plus a column of                    millimeter values (# # mm), excluding values from                    rows that are not selected for fusion.                -   A fifth column:                -    header label “D. MAXIMUM ANTICIPATED ANTERIOR                    SUBSIDENCE*”                -    plus two sub-columns, with each sub-column only                    containing data for those levels that are selected                    for fusion:                -    the first with sub-column header label “computed                    value” and a column of millimeter values (# # mm)                -    the second with sub-column header label                    “User-Edited Value” a column of Edit boxes with                    up/down increment buttons, defaulted to the value                    from User Config, and containing millimeter values                    (#.# mm)                -   A sixth column                -    with header label “E. CORRECTION FOR ANTICIPATED                    SUBSIDENCE**”                -    plus two sub-columns, with each sub-column only                    containing data for those levels that are selected                    for fusion:                -    the first sub-column header label “computed value”                    contains a column of degree change values (+#° and                    −#°)                -    the second sub-column header label “User-Edited                    value” Edit boxes with up/down increment buttons,                    containing degree change values (+#° and −#°),                    defaulted to the computed value.                -    Underneath the sixth column are two values, one for                    each sub-column, which is the sum of the sub-column,                    in degree change values (+#° and −#°), and with the                    label “Sum=” to the left.        -   There can be a label on the bottom of the frame for notes:            -   “* This estimate of potential lordosis loss due to                subsidence is a geometric calculation based on the                individual vertebral body dimensions of each patient.                This calculation uses an assumed “Maximum Anticipated                Anterior Subsidence” which represents the upper end of                expected subsidence. Consider adjusting upward from the                default value when patient has poor bone quality or when                interbody device placement is posterior. Consider                adjusting downward from the default if the level                receives anterior fixation or when interbody device                placement is anterior.            -   ** Formula for E: θ=ArcTangent (Length/D);                Length=A/2+B/2−C″        -   There can be Save button, which system can save the changes            made since the modal window has been active, then close the            window and return control to the referring page        -   There can be Cancel button, which system can undo all of            edits made since the modal window was popped up, then close            the window and return control to the referring page    -   Calibrate (D)        -   There can be the title “Collect Grid Calibration Image:        -   There can be instructions: “The C-arm can be calibrated.            Please capture an image of the grid. For more information            about how to properly capture the grid image, please press            help. Below is an image that is coming from the fluoroscope.            Please capture a grid image on the fluoroscope, and when a            grid image appears below press “Accept Image” to continue.”        -   There can be a help button that pulls up a help screen        -   There can be a space for the fluoro image feed that can be            the native size of the image. (optimized for 1 k×1 k pixels,            but able to accept up to 2 k×1.5 k)        -   There can be an “Accept Image” button, that when pressed            system can:            -   grab the current image, and save it to the [CALIBRATE                DATA] data structure            -   derive a correction matrix from the saved calibration                image, and save this to the [CALIBRATE DATA] data                structure.            -   Change the status variable [CALIBRATED YET] to TRUE                Close the window and return the user to the referring                page.                -   In the case that the user came to the Calibrate (D)                    modal window after having pressed “Grab Frame” then                    “OK” on the Capture Screen, then the user system can                    return to the Capture Screen, and resume the set of                    actions specified to occur directly following the                    check that is done on the status variable [CALIBRATE                    STATUS] that occurs after the user presses “Grab                    Frame”.        -   There can be a “Cancel” button, that when pressed does one            of two things:            -   If the user came to the Calibrate (D) modal window after                having pressed “Grab Frame” then “OK” on the Capture                Screen, then:                -   a message pop-up will be displayed “Cancelling the                    calibration will make it impossible to continue with                    the prior video capture action, and the image that                    was captured will be lost. Press “CANCEL & LOSE                    PRIOR CAPTURE” or “GO BACK TO FINISH CALIBRATION””.                -   If user selects “Cancel”, then: (1) the message                    pop-up and the Calibrate modal window can be                    closed, (2) return active control to the Capture                    screen, which itself will have a pop-up message                    open, which system can close, and (3) on the Capture                    screen the live video feed system can resume in the                    Image Section.                -   If user selects “Go back”, then the message window                    system can close and active control system can                    revert back to the Calibrate modal window.            -   ELSE, close the window and return the user to the                referring page.

Configure Screens

-   -   The Configure Screen system can have visible and active a “Save”        and a “Cancel Button”.    -   The same upper frame and buttons from the upper right section of        the Main Screen (with the Exit and Load Patient button) system        can be active and visible on the Configure Screen.    -   Upon pressing “Save”, a pop-up click-through agreement is served        to the user:        -   The agreement system can present the text:            -   “All of the preceding user configurations represent my                personal medical judgment. The convenience features                included in this software do not represent a specific                medical diagnosis and it is my responsibility to                determine their clinical significance, if any, based my                training, experience and relevant clinical                circumstances. I further understand and acknowledge that                the vertebral motion analysis can be based on                automatically or semi-automatically generated data, and                that I can manually review all potentially clinically                relevant information before relying upon any data                presented via the system for clinical decision making            -   I understand that the Company will be storing my user                configuration data, and will treat this information as                confidential and secure it to the same extent it secures                protected patient health information. I have read and                understand the above.”        -   The user can be presented with buttons “I Agree” or “Cancel”            -   Pressing “Cancel” system can revert active control back                to the Config Screens.            -   Pressing “I Agree” system can:                -   Update the data associated with the surgeon user to                    note that the click-through agreement has been                    executed (see the section “Functional Features: Data                    saving and storage”).                -   Close the pop-up                -   Revert active control back to the page the user was                    on prior to pressing the “Configure” button.    -   There can be four tabs on the Configure Screen    -   There can be a first tab labeled “OPTIONS”        -   There can be a section labeled “Default Image Viewing            Options”            -   There can be a sub-section labeled “OVERLAYS”. There can                be a column of 5 items, each item comprised of a                checkbox (all defaulted to on), icon, and label, and                said item labels being “Target Construct”, “Current                Capture”, “Reference View”, “Mobility Range”, “Gravity                (plumb)”            -   There can be a sub-section labeled “DISPLAY OPTIONS”.                -   There can be a checkbox labeled “Images” (defaulted                    to on)                -   Indented from the “Images” label, there can be a set                    of three radio buttons labeled “Reference View”,                    “Target Construct”, and “Current Capture”. Default                    value is “Current Capture”                -   There can be a checkbox labeled “Labels” (defaulted                    to on)            -   There can be a sub-section labeled “ORIENTATION”.                -   There can be a set of three radio buttons labeled                    “Reference View”, “Current Capture”, “Native”, and                    “Gravity”. Default value is “Gravity”                -   Next to the “Gravity” label, and visible when the                    “Gravity” radio button is selected, is a drop box                    labeled “If unavailable, use”, that allows the user                    to select from a list of “Current Capture” and                    “Native”, which comes defaulted to “Native”            -   There can be a sub-section labeled “LINEAR                MEASUREMENTS”.                -   There can be a set of three radio buttons labeled “%                    Max. Range”, “Millimeters”, and “% Vertebral Body                    Depth”. Default value is “Millimeters”        -   There can be a sub-section labeled “DEFAULT REFERENCE VIEW”.            -   There can be two sub-areas, connected by a selector                object that allows the user to select between the two                sub-areas (defaulted to select the first sub-area                -   The first sub-area can be labeled “MIN/MAX VIEWS”,                    and can have two sets of radio buttons. The first                    set can have two radio buttons labeled “MM.” and                    “Max.” (Defaulted to Max.). The second set can have                    four radio buttons labeled “Lordosis”, “Reduction”,                    “Anterior Disc Height”, “Posterior Disc Height”                    (defaulted to Lordosis).                -   The second sub-area can be labeled “SPECIFIC VIEWS”,                    and can have two sets of radio buttons. The first                    set can have five radio buttons labeled “Standing,                    NO device, bending views”, “Standing, WITH device,                    bending views”, “Side-lying, bending views”,                    “Supine, neutral view” and “Prone, neutral view”                    (defaulted to “Standing, NO device, bending                    views”.). The second set can have three radio                    buttons labeled “Neutral”, “Flexion”, and                    “Extension” (defaulted to neutral).                -    This second set of three radio buttons can be                    ghosted/inactive if the first set of radio buttons                    assumes either of the values “Supine, neutral view”                    and “Prone, neutral view”        -   There can be a sub-section labeled “Default Comparison View            (during Capture)”.            -   There can be two sub-areas, connected by a selector                object that allows the user to select between the two                sub-areas (defaulted to select the second sub-area)                -   The first sub-area can be labeled “MIN/MAX VIEWS”,                    and can have two sets of radio buttons. The first                    set can have two radio buttons labeled “MM.” and                    “Max.” (Defaulted to Max.). The second set can have                    four radio buttons labeled “Lordosis”, “Reduction”,                    “Anterior Disc Height”, and “Posterior Disc Height”                    (defaulted to Reduction).                -   The second sub-area can be labeled “SPECIFIC VIEWS”,                    and can have two sets of radio buttons. The first                    set can have five radio buttons labeled “Standing,                    NO device, bending views”, “Standing, WITH device,                    bending views”, “Side-lying, bending views”,                    “Supine, neutral view” and “Prone, neutral view”                    (defaulted to “Supine, neutral view”.). The second                    set can have three radio buttons labeled “Neutral”,                    “Flexion”, and “Extension” (defaulted to neutral).                -    This second set of three radio buttons can be                    ghosted/inactive if the first set of radio buttons                    assumes either of the values “Supine, neutral view”                    and “Prone, neutral view”            -   There can be a checkbox labeled “Same as Default                Reference View” which, when selected, will copy the                selections in the Default Reference View into this                section.    -   There can be a second tab labeled “TARGET CONSTRUCT”        -   There can be a section labeled “Assumptions for Determining            Sagittal Alignment Corrections”, which can be split into two            sub-sections            -   There can be a set of two radio buttons, each one                located at the top of each subsection, labeled                “Rothenfluh, 2014” and “Roussouly, 2005).            -   Next to each radio button label, there is an icon “i”                which system can bring up an image labeled either                [ROTHENFLUH IMAGE] or [ROUSSOULY IMAGE].            -   Underneath the “Rothenfluh, 2014” radio button:                -   There can be an edit box with up/down increment                    buttons, labeled “Target Post-Op PI-LL:”, value in                    degrees)(#°, defaulted to 10 degrees.                -   There can be a label “Default constructs include                    PI-LL correction (if PI-LL is less than target)?”                -    Underneath the label can be a set of two radio                    buttons, labeled “Include Correction in Default” and                    “Default does NOT include Correction” (defaulted to                    Corrected)            -   Underneath the “Roussouly, 2005” radio button, there can                be the label “Roussouly method involves manually                inputting the target angles for the upper and lower                lumbar arcs.”        -   There can be a section labeled “Assumptions for Distributing            Segmental Lordosis. Select a Lordosis Distribution Function.            This is simply a set of five percent values, which sum to            approximately 100%. This represents the segmental lordosis            at each level as a % of total lumbar lordosis.”            -   Underneath the label there can be a 5×4 matrix of data:                -   A set of five columns header labels “L1/L2” . . .                    “L5/S1”                -   A set of four radio buttons with labels: “Panjabi,                    et. al. (1992)”, “Stagnara, et. al. (1998)”,                    “Average”, and “User-defined”. The radio button                    labels serve as row header labels. The default value                    is “Average”                -   There can be an “i” icon to the right of the                    “Average” label that system can bring up an image                    labeled [DISTRIBUTION FUNCTIONS IMAGE].                -   The first three rows can have the values displayed                    in FIG. 11:                -   The last row can be a set of user editable text                    boxes, defaulted to null, which allows a user to                    input a value between 1 and 100. Editing any of                    these boxes changes the radio button to be equal to                    “User-Defined”.                -    Whenever data is entered and then saved, a                    normalized distribution function can be calculated                    and used whenever the distribution function data is                    used by the software, which can be normalized such                    that the sum of the five user-entered values can be                    equal to 100%.        -   There can be a section labeled “Calculation Assumptions”            -   There can be three edit boxes with up/down increment                buttons, each defaulted to 2 and capable of assuming the                values 1-4.            -   The labels on these edit boxes can be “Minimum number of                non-excluded levels for the “Lordosis” calculation”,                “Minimum number of non-excluded levels for the “Disc                Height” calculation”, and “Minimum number of                non-excluded levels for the “Offset” calculation”    -   There can be a third tab labeled “SUBSIDENCE”        -   There can be a section labeled “Default”, which can have:            -   A checkbox labeled “Include additional lordosis to                offset potential subsidence-related lordosis loss?*”,                defaulted to on.            -   An edit box with up/down increment buttons, displaying a                value in millimeters (# # mm), defaulted to 2.0                millimeters        -   There can be a section labeled “MASS* Adjustment            Assumptions”            -   A checkbox labeled “Adjust the MASS* value when gravity                and the level are close to parallel?”, defaulted to on.            -   An label, edit box with up/down increment buttons,                second label, a second edit box with up/down increment                buttons, and a third label                -   First edit box: label to the left of the edit box                    “Reduce MAAS* by”, value is millimeters (#.# mm),                    defaulted to −1.0 mm                -   Second edit box: label “when gravity and the level                    are within”, value is in degrees)(##°, defaulted to                    30 degrees                -   The third label: “degrees of being parallel (in                    standing, NO device, neutral view).”        -   There can be a section labeled “Assumed Implant Dimensions            (for the geometric calculations)”            -   There can be two scales of 10 to 50 millimeters, on                which users can specify whole number points (i.e. the                sliders “snap” to the whole numbers).            -   The first scale can be labeled “VERTEBRAL BODY SIZE                DEFINITIONS (anterior-posterior depth in millimeters)”                -   This scale can have two points defined by the user,                    corresponding to three contiguous regions labeled                    “Small”, “Medium” and “large”.                -   The default values can be: Small-Medium: 30 mm;                    Medium-Large: 35 mm            -   The second scale can be labeled “ASSUMED RANGE OF                INTERBODY DEVICE SIZE (anterior-posterior depth in                millimeters)”                -   This scale can have six points defined by the user,                    corresponding to three ranges labeled “Small”,                    “Medium” and “large”, with each range comprising two                    points (start, end), which may or may not overlap or                    be contiguous.                -   The default values are:

Range of Interbody Device A/P Depth Start End 14 mm 22 mm 18 mm 26 mm 22mm 30 mm

-   -   -   -   -   There can be the footnote: “*This estimate of                    potential lordosis loss due to subsidence is a                    geometric calculation based on the individual                    vertebral body dimensions of each patient. This                    calculation uses an assumed “Maximum Anticipated                    Anterior Subsidence” which represents the upper end                    of expected subsidence. Consider adjusting upward                    from the default value when patient has poor bone                    quality or when interbody device placement is                    posterior. Consider adjusting downward from the                    default if the level receives anterior fixation or                    when interbody device placement is anterior.”

    -   There can be a fourth tab labeled “ALERTS”        -   There can be a section labeled “Surgical Considerations”,            which can have a 3×4 matrix of data and objects:            -   The first row can have the following three elements: an                “Alert text” label, a second item comprised of a yellow                triangle alert icon plus an edit box defaulted to the                value “Possible”, and a third element comprised of a red                triangle alert icon plus an edit box defaulted to the                value “Likely”            -   Rows 2-4 in the first column system can contain edit                boxes defaulted to the values “Smith Peterson                osteotomy”, “Pedicle subtraction osteotomy (PSO)”, and                “ALL release procedure”            -   Cell (2,2) can have “Target PDH<X % PDH @ standing                neutral”, where X is an edit box (#%) defaulted to 100%.            -   Cell (2,3) can have “Target PDH<X % minimum PDH across                all images”, where X is an edit box (#%) defaulted to                100%.            -   Cell (2,4) can have “Target ADH>X % maximum ADH across                all images”, where X is an edit box (#%) defaulted to                125%.            -   Cell (3,2) can have “Target PDH<X % minimum PDH across                all images”, where X is an edit box (#%) defaulted to                100%.            -   Cell (3,3) can have “Target PDH is less than X”, where X                is an edit box (# mm) defaulted to 0 mm            -   Cell (3,4) can have “Target ADH>X % maximum ADH across                all images”, where X is an edit box (#%) defaulted to                150%.        -   There can be a section labeled “Sagittal Alignment Alert            Thresholds”, which can have a 2×2 matrix of data and            objects:            -   The 2 row labels can be “Rothenfluh” and “Roussouly”            -   There can be no column header labels.            -   Cell (1,1) can have a yellow triangle alert icon, and an                edit box with up/down increment buttons, label “PI-LL≧”,                value is in degrees)(##°, defaulted to 8 degrees            -   Cell (2,1) can have a red triangle alert icon, and an                edit box with up/down increment buttons, label “PI-LL≧”,                value is in degrees)(##°, defaulted to 10 degrees            -   Cell (2,1) can have two sub-sections, connected by a                drop-down box that can select from the list of “AND” and                “OR” (defaulted to “OR”)                -   The first sub-section can be a set of four                    checkboxes, with labels “Type 1”, “Type 2”, “Type                    3”, and “Type 4”. Defaulted to Type 1 and Type 2                    being on.                -   The second sub-sections system can consist of an                    edit box with up/down increment buttons with a label                    on top, which is on top of a second edit box with                    up/down increment buttons with a label on top, which                    is on top of a third label:                -    First edit box: label “Pelvic Tilt between”, value                    is degree)(#°, defaulted to −25 degrees.                -    Second edit box: label “and”, value is degree)(#°,                    defaulted to 30 degrees.                -    The third label: “inclusive”            -   Cell (2,2) can have two sub-sections, connected by a                drop-down box that can select from the list of “AND” and                “OR” (defaulted to “AND”)                -   The first sub-section can be a set of four                    checkboxes, with labels “Type 1”, “Type 2”, “Type                    3”, and “Type 4”. Defaulted to Type 1 and Type 2                    being on.                -   The second sub-sections system can consist of an                    edit box with up/down increment buttons with a label                    on top, value is degree)(#°, defaulted to 30                    degrees.

Status Variable Features

-   -   There can be a Boolean status variable [CALIBRATED YET]        -   The default value is FALSE        -   The value changes to TRUE the user pressing the “Accept            Image” button on the Calibrate (D) modal window and the            function to derive the correction matrix executes            successfully.    -   There can be a status variable [CAPTURE STATUS] that is        associated with each level.        -   The possible values can be: “No Capture Yet” or “Current            Capture with no prior captures” or “Current Capture with            Prior captures”        -   The default value can be “No Capture Yet”        -   The value of [CAPTURE STATUS] can be determined by the set            of instances of [CAPTURE DATA]. For all instances, count the            number of instances for which [MARKUP STATUS]=Step 5 and            [MARKUP SAVE STATUS]=“Saved”:            -   “No Capture Yet” whenever the count is zero            -   “Current Capture with no prior captures” whenever the                count is 1            -   “Current Capture with Prior captures” whenever the count                is 2 or greater.    -   There can be a status Variable [MARKUP STATUS], [MARKUP LEVEL],        and [MARKUP SAVE STATUS] associated with Capture Image        -   These variables can be able to assume the values:            -   [MARKUP STATUS]: Step 0 to Step 5            -   [MARKUP LEVEL]: “Unspecified”, “L1/L2” . . . “L5/S1”            -   [MARKUP SAVE STATUS]: “Saved” or “Unsaved”        -   These variables system can get initiated each time the user            presses “Grab Frame” on the Capture Screen, (which triggers            the creation a new instance of the [CAPTURE IMAGE] dataset).            -   [MARKUP STATUS] is set to Step 0            -   [MARKUP LEVEL] is set according to which radio button is                selected. If no radio button is selected (i.e. [ACTIVE                LEVEL]=Null), then this is defaulted to the value                “Unspecified”            -   [MARKUP SAVE STATUS] is set to “Unsaved”        -   The [MARKUP LEVEL] Variable can be changed by the user at            any time by interacting with the radio buttons at the top of            the left pane of the Capture Screen.        -   The [MARKUP LEVEL], [MARKUP LEVEL], and [MARKUP SAVE STATUS]            variable can also be changed according to the workflow            described in the Capture Screen section of this document.    -   There can be the status variable [ADDITIONAL LORDOSIS FOR SA        CORRECTION STATUS] that is associated with each user session.        -   The possible values can be: null, “Not Confirmed” or            “Confirmed”        -   The default value can be:            -   If user config specifies Rothenfluh AND                -   if user config specifies that PI-LL corrections ARE                    to be included in the default, then the default                    value can be “Not Confirmed”.                -   Else, then the default value can be null            -   If user config specified Roussouly, then the default                value can be null        -   The value of [ADDITIONAL LORDOSIS FOR SA CORRECTION STATUS]            can be changed by any one of the two actions below, and once            it changes its value from the default it typically does not            revert to any other value            -   On the Surgery Summary Object: (1) clicking on the “OK”                on the button next to the Additional Lordosis edit                box, (2) editing a value into this edit box, or (3)                using the plus or minus increment buttons.            -   On the Lordosis Distribution Calculations, Rothenfluh                (B1) modal window, pressing the “Save Button”                (regardless of whether or not any values had been edited                while the modal window had been active)    -   There can be a Boolean status variable [CHECKBOX COLUMNS ACTIVE]        associated with each of the columns of checkboxes for excluding        Disc Height and Offset.        -   The default value can be TRUE        -   The value of [CHECKBOX COLUMNS ACTIVE] changes to FALSE            whenever, on the Edit Midline Disc Height (A1) or Edit            Offset (A2) modal window, any of the values in the rightmost            column differ from the computed average (after exclusions)    -   There can be a status Variable [ACTIVE LEVEL] associated with        each patient use sessions        -   The possible values can be: null, “L1/L2” . . . “L5/S1”        -   The default value can be null        -   The value of [ACTIVE LEVEL] can be changed by any one of the            three actions:            -   The user clicking one of the five tabs (“L1/L2” . . .                “L5/S1”) from within the set of seven tabs that is                present on the upper portion of the left pane of both                the Main Screen and capture Screen. When this occurs,                ACTIVE LEVEL is set to the level that the user clicks.            -   The user selecting a level in the upper portion of the                left pane of the Capture Screen.            -   The user completing a four point markup of a level's                disc space while on the Capture Screen. When this                occurs, ACTIVE LEVEL is set to the level that underwent                the 4 point markup.    -   There can be status Variables [REFERENCE VIEW] and [COMPARE        PRIOR MARKUP VIEW] associated with each patient use sessions        -   These Variables comes defaulted to the view specified in the            User Config pages.        -   These variables are changeable wherever there is: (1) a drop            down labeled “reference View” for [REFERENCE VIEW], or (2) a            drop down labeled “Compare to Prior Spine Markup” for            [COMPARE PRIOR MARKUP VIEW]        -   Each of the [REFERENCE VIEW] items below may or may not have            gravity data, however the Standing NO Device, neutral view            can have gravity data        -   These variables can assume the following values (also note            the values below are the [VIEW TEXT] text string which            appears in labels in some other sections of the software)            -   Min/Max Views (there is an image for this)                -   Max Lordosis                -   Max Reduction                -   Max ADH                -   Max PDH                -   Min Lordosis                -   Min Reduction                -   Min ADH                -   Min PDH            -   Specific Views (These only display if they exist):                -   Standing NO Device Neutral                -   Standing NO Device Flexion                -   Standing NO Device Extension                -   Supine                -   Prone                -   Standing WITH Device Neutral                -   Standing WITH Device Flexion                -   Standing WITH Device Extension                -   Lying WITH Device Neutral                -   Lying WITH Device Flexion                -   Lying WITH Device Extension            -   Prior Capture (this section of the list is only active                if [CAPTURE STATUS] is set to “Current Capture with                Prior captures”                -   There can be a list of all previous prior, with each                    prior capture labeled as “X capture(s) ago                    ([time/date stamp]), [“markup complete” or “markup                    not complete”]”.                -    If [CAPTURE STATUS] “No Capture Yet”, then the text                    above system can include the element “markup not                    complete”, else this can be “markup complete”.                -   Each element on the list of Previous captures can be                    visible, if the prior captures has [MARKUP STATUS]                    of Step 5 and [MARKUP SAVE STATUS] of “Saved”

Data Structure Features:

-   -   An array of computed values based on default values, which        system can get updated upon any change to the user config        variables and change to the levels selected for fusion, but        otherwise do not change throughout a testing session        -   Additional Sagittal Alignment correction, by level            (segmental) and across all level selected for fusion s        -   Correction for Anticipated Subsidence, by level and across            all levels selected for fusion        -   Maximum Anticipated Anterior Subsidence (MAAS), by level.        -   Target Construct default values, by level and across all            levels selected for fusion        -   Total Segmental lordosis for all levels selected for fusion            (adding all of the above three items)    -   An array of current values, as edited by the user:        -   via direct edit on an edit box            -   Sagittal Alignment correction, by level and across all                level selected for fusion s            -   Correction for Anticipated Subsidence, Maximum                Anticipated Anterior Subsidence, Assumed Implant Length,                by level            -   Total Segmental lordosis (adding all of the above three                items)            -   Midline Disc Height and Offset.        -   via grab/drag or drag/rotate actions in the Disc Space            Diagram.            -   Target Construct values (lordosis, Midline disc height,                offset)        -   via selections/deselections from checkbox arrays            -   Levels selected for fusion            -   Levels selected for exclusions for lordosis, disc                height, and offset        -   Via an array of dropdowns:            -   Lordosis data source by level    -   An array of current calculated values, based on the array of        current user-set values, which system can include all of the        variables specified to be calculated in the “Calculation        Features” section. Note these are the values that get calculated        based off the combination of default values and current values        (as edited by the user).    -   There can be a data structure [CALIBRATE DATA] which can be        created/updated upon a calibrate action (see Calibrate modal        window), and which system can store an instance of an image and        a correction matrix associated with the calibration action.    -   There can be a data structure [CAPTURE DATA], which can be        created upon a video capture action that occurs in the Capture        Screen        -   Current Capture Image—This system can contain the image file            that is created with the video capture action        -   [MARKUP STATUS]—This can be a status variable (See Status            Variable Features Section). This can assume the values Step            0 through Step 5        -   [MARKUP LEVEL]—This can be a status variable (See Status            Variable Features Section). This can assume the values            “Unspecified”, “L1/L2” . . . “L5/S1”.        -   [MARKUP POINTS]—This is 4 coordinate (x,y) sets representing            pixel locations relative to the Current Capture Image. The 4            coordinate sets are named: 1_INF_VERT_POST_SUP_CORNER,            2_INF_VERT_ANT_SUP_CORNER, 3_SUP_VERT_POST_INF_CORNER,            4_SUP_VERT_ANT_INF_CORNER        -   [MARKUP SAVE STATUS]—This can be a status variable (See            Status Variable Features Section). This can assume the            values “Saved” and “Unsaved”.

Alerts Features:

-   -   Alerts can have the following attributes: Severity (null,        yellow, red), Short text (2 or 3 upper case letters), and a long        text (a constructed text string).    -   There can be two types of alerts (Surgical Considerations and        Sagittal Alignment alerts), each having its own set of        icon/short text items as well as long text items        -   Surgical consideration alerts (PSO, SP, ALL)            -   These alerts can be structured as a posterior alert and                an anterior alert, each of which can be activated or                deactivated independently.            -   The icon/short text version:                -   Anterior alerts can be of either one or two                    configurations:                -    Triangle/Triangle (“Δ XXX/Δ XXX”), in the case that                    an SP and a PSO alert we both activated.                -    Triangle (“Δ XXX”), in the case that one or the                    other was activated                -   Posterior alerts system can only be of the Triangle                    (“Δ XXX”) configuration, and can be of the type ALL.            -   The long text system can comprise the string: [STRING1]                & “.” & [STRING2].                -   STRING1: Defined by User Config, as the combination                    of the [DESC COLOR] & [DESC PSO, SP, ALL]. For                    example “Likely Smith-Peterson osteotomy” or                    “Potential ALL release procedure”                -   STRING2: Threshold text: Defined by User Config. For                    example: Yellow/PSO: “Target PDH<100% minimum PDH                    across all images”. Red/SP: Target ADH>150% maximum                    ADH across all images”        -   Sagittal Alignment alerts (SA).            -   The icon/short text version of the Sagittal Alignment                alerts is “Δ SA”.            -   The long text can be structured differently depending on                whether the user configuration specified the                “Rothenfluh” or the “Roussouly” method for determining                Sagittal Alignment corrections.                -   For users configured to “Rothenfluh”: Long Text:                    system can comprise two strings, joined together:                    [STRING1] & “.” & [STRING2].                -    STRING1: “Potential Sagittal Alignment issues:”                -    STRING2: Select which applies: “PI LL is between X                    and Y” [this potentially applies to the yellow                    condition], “PI LL is above Y.” [this potentially                    applies to the red condition]. NOTE: X and Y are the                    User Config threshold values.                -   For users configured to “Roussouly”, there system                    can comprise two strings, joined together: [STRING1]                    & “.” & [STRING2].                -    STRING1: “Potential Sagittal Alignment issues:”                -    STRING2: Include all that apply: “Type X                    Lordosis.”, “Pelvic Tilt between X and Y” [this                    potentially applies to the yellow condition],                    “Pelvic Tilt is above Y.” [this potentially applies                    to the red condition]. NOTE: X and Y are the User                    Config threshold values.    -   There can be the following alerting functionality on the        following objects:        -   Left Pane: Sagittal Alignment Diagram.            -   For either Rothenfluh or Roussouly type Sagittal                Alignment alerts, the alert icons Plus the short text                can be visible when activated (see details in the                Sagittal Alignment Diagram section for more info on                placement).            -   When one of the alert icons and short text is visible,                when the user moves the mouse over the icon/text, a text                box pops up with the Long Text for the alert.        -   Left Pane: Disc Space View Diagram:            -   The following alert items can be visible when activated:                -   For the Rothenfluh type Sagittal Alignment alerts,                    the alert icon Plus the short text can be visible                    when activated (this appears on the rightmost column                    of the Dimensions Table).                -   For Surgical consideration alerts, the alert icons                    plus short text can be visible when activated (this                    appears on the Distance From/To Diagram). See Disc                    Space View Diagram section for more details on                    placement.            -   When one of the alert icons and short text is visible,                when the user moves the mouse over the icon/text, a text                box pops up with the Long Text for the alert.        -   Right Pane: Surgery Summary:            -   The following alert items can be visible when activated:                -   For Rothenfluh & Roussouly type Sagittal Alignment                    alerts, the alert icon Plus the short text can be                    visible when activated (this appears in the middle                    section, see Surgery Summary section for more                    details on placement)                -   For Surgical consideration alerts, the alert icons                    plus short text can be visible when activated (this                    appears column next to the column of checkboxes with                    the column header label “Fusion at this level?”)            -   When one of the alert icons and short text is visible,                when the user moves the mouse over the icon/text, a text                box pops up with the Long Text for the alert.        -   Right Pane: Level Summary Surgical Considerations            -   In the upper sub panel for Surgical Considerations, each                alert icon, short text, and long text are presented (Up                to three sets possible, no mouse-over popups, format “Δ                XXX: [LONG TEXT STRING]”. Note that the icon/short text                is different here than described above for the anterior                alerts. In that section, a single combined icon/short                text is created in the case that both SP and PSO alert                is triggered. In this section, each gets its own row,                and there is no single combined icon displayed in the                case that both SP and PSO alerts are triggered).

Calculation Features:

-   -   There is a set of sequential calculations steps which provide        updates to the Sagittal Alignment Diagram, Disc Space Diagram,        Surgery Summary Object, Level Summary Object:        -   can be triggered by a range of actions, each action            triggering a the calculations to start at a potentially            different point in the calculation sequence:            -   Actions that lead to the need to do the first, second,                and third steps:                -   Main Page: Surgery Summary object—Direct editing the                    [Additional Lordosis for Sagittal Alignment                    Corrections], [Upper Arc Additional Lordosis],                    [Lower Arc Additional Lordosis), changing the level                    excluded from lordosis calculations                -   Main Page: Level Summary object—Directly editing                    [Total Segmental Lordosis], [Additional Segmental                    Lordosis for Sagittal Alignment Correction],                    [Segmental Correction for Anticipated Subsidence],                    or [Maximum Anticipated Anterior Subsidence]                -   Main Page: Disc Space Diagram—Grab/rotate target                    construct line.                -   Edit Lordosis (A3) modal window—Changing the levels                    excluded from lordosis calculations                -   Lordosis Distribution Calculations modal                    windows—Editing [Additional Segmental Lordosis for                    Sagittal Alignment Corrections] (there may be up to                    five values, and the calculation is triggered by                    changes to any one of the up to five values),                    [Additional Lordosis for Sagittal Alignment                    Corrections], [Upper Arc Additional Lordosis],                    [Lower Arc Additional Lordosis],                -   Edit Correction for Anticipated Subsidence modal                    window: Directly editing [Assumed Implant Length],                    [Segmental Correction for Anticipated Subsidence],                    or [Maximum Anticipated Anterior Subsidence]            -   Actions that lead to a recalculation of the second and                third steps include:                -   Main Page: Surgery Summary object—changing the                    levels excluded from either disc height and offset                    calculations.                -   Main Page: Disc Space Diagram—Grab/Drag of the                    Target Construct line                -   Edit Midline Disc Height (A1 modal window: editing                    the Average Disc Height. (there may be up to five                    values, and the calc is triggered by changes to any                    one of the up to five values)                -   Edit Offset (A2) modal window: editing the Average                    offset. (there may be up to five values, and the                    calculation is triggered by changes to any one of                    the up to five values)            -   Actions that lead to the recalculation of the third                step:                -   Main Page: Surgery Summary object—changing the                    Lordosis Data source at a level.        -   First Step: Calculate Segmental Lordosis At each Level            selected for fusion.            -   The sum equation for this calculation is

[Total Segmental Lordosis]=[Target Segmental Lordosis]+[AdditionalSegmental Lordosis for Sagittal Alignment Correction]+[SegmentalCorrection for Anticipated Subsidence].

-   -   -   -   This calculation can be performed upon any of the four                user actions                -   User directly inputs [Total Segmental Lordosis]                -    This can be done via grab/rotate of the Disc Space                    Diagram, or by Direct Editing on the Level Summary                    Object.                -    As the [Total Segmental Lordosis] value is changed                    by the user, the [Additional Segmental Lordosis for                    Sagittal Alignment Correction] is changed to keep                    the sum equation in balance.                -   User changes [Target Segmental Lordosis]:                -    This can be done via changing the set of levels                    excluded from lordosis calculations via interacting                    with the “exclude” checkboxes on the Surgery Summary                    page or the Edit Lordosis window                -    As this value is changed, the [Total Segmental                    Lordosis] is changed to keep the sum equation in                    balance.                -   User changes the [Additional Segmental Lordosis for                    Sagittal Alignment Correction]                -    This can be done via:                -    Directly editing the [Additional Segmental Lordosis                    for Sagittal Alignment Correction] on the Level                    Summary Object and the Lordosis Distribution                    Calculations modal windows                -    In the case of                -    ROTHENFLUH: Directly editing the [Additional Total                    Lordosis for Sagittal Alignment Correction] in the                    Surgery Summary Object and the Lordosis Distribution                    Calculations modal window.                -    ROUSSOULY: Directly editing the either the [Upper                    Arc Additional Lordosis] or the [Lower Arc                    Additional Lordosis] for Sagittal Alignment                    Correction in the Surgery Summary Object and the                    Lordosis Distribution Calculations modal window.                -    In either case, as this revised number is                    distributed across levels, the [Additional Segmental                    Lordosis for Sagittal Alignment Correction] system                    can change.                -    Selecting or deselecting additional levels for                    fusion, on the row of checkboxes on the tabs on the                    upper part of the left pane, or on the column of                    checkboxes on the Surgery Summary Object                -    As the [Additional Segmental Lordosis for Sagittal                    Alignment Correction] value is changed by the user,                    the [Total Segmental Lordosis] is changed to keep                    the sum equation in balance.                -   User changes the [Segmental Correction for                    Anticipated Subsidence]                -    This can be done via:                -    direct edits to the [Segmental Correction for                    Anticipated Subsidence] via in the Level Summary                    Object and the Edit Correction for Anticipated                    Subsidence modal window                -    Whenever [Segmental Correction for Anticipated                    Subsidence] changes, the value for [Maximum                    Anticipated Anterior Subsidence] changes as well,                    and the value for [Assumed Implant Length] is held                    constant                -    Direct edits to the [Maximum Anticipated Anterior                    Subsidence] number via in the Level Summary Object                    and the Edit Correction for Anticipated Subsidence                    modal window                -    Direct edits to the [Assumed Implant Length] number                    via in the Edit Correction for Anticipated                    Subsidence modal window                -    [Segmental Correction for Anticipated Subsidence],                    θ, system can change whenever the Maximum                    Anticipated Anterior Subsidence number (D) or the                    Assumed Implant Length number (B) changes:                    θ=ArcTangent [(A/2+B/2−C)/D]. Note: A=Length of                    superior edge of inferior vertebral body (from                    vertebral motion analysis). C=Offset (from vertebral                    motion analysis).                -    As the [Segmental Correction for Anticipated                    Subsidence] value is changed by the user, the [Total                    Segmental Lordosis] is changed to keep the sum                    equation in balance.                -    As will be appreciated by those skilled in the art,                    that there is one mechanism by which the for                    [Segmental Correction for Anticipated Subsidence] is                    automatically or semi-automatically updated by the                    system, via an automated or semi-automated                    adjustment to the [Maximum Anticipated Anterior                    Subsidence] number, which also trigger a                    recalculation according to this first step. See the                    description of the automatic adjustment later in                    this Calculation Features section, in the section                    titled “Computed values for [Segmental Correction                    for Anticipated Subsidence]”            -   Second Step: Calculate Geometric Transform at each level                selected for fusion to Update the Disc Space Diagram and                Distance From/To Diagrams                -   The calculation is:                -   The input for this calculation can be                -    depth of                -    the inferior vertebral body's superior endplate                -    the superior vertebral body's inferior endplate                -    Midline Disc Height                -    Offset                -    [Total Segmental Lordosis]                -   This calculation can be performed according to the                    diagram of FIG. 12.                -   The process steps of the Calculation can be:                -    Origin is posterior superior corner of inferior                    vertebral body (point A).                -    Horizontal origin is defined by point B, which gets                    placed along the horizontal origin at a distance                    from A equal to the depth of the inferior vertebral                    body's superior endplate.                -    Point C is placed on the midpoint between A and B,                    moved upward to the midline disc height (avg. of PDH                    and AHD)                -    Place a line going through C that is parallel to                    the [Total Segmental Lordosis].                -    Place a point D along that line, such that the                    distance between A and D along the AB line is equal                    to the offset                -    Place point E along that line at a distance from D                    equal to the depth of the superior vertebral body's                    inferior endplate                -   The Output of this geometric transform is                -    Coordinates of A, D, E, and B. A=0,0                -    ADH: Length of the line dropped from D to the                    intersection of AB.                -    PDH: Length of line dropped from E to the                    intersection of AB.            -   The calculation is triggered by any of the following 3                actions:                -   Performance of the First Step above.                -   User Changes the Average Midline Disc Height, either                    by excluding level via interacting with the                    “exclude” checkboxes on the Surgery Summary page or                    the Edit Midline Disc Height modal window.                -   Changing the Average Offset, either by excluding                    level via interacting with the “exclude” checkboxes                    on the Surgery Summary page or the Edit Offset modal                    window.

        -   Third Step: Calculate Geometric Transform across all levels            to update the Sagittal Alignment Diagram            -   The calculation is:                -   Stack Levels on top of levels, using the appropriate                    geometric points based on the current value of the                    Lordosis Data Source (from the Surgery Summary                    Object), to produce a new set of coordinates for the                    vertebral bodies and labels in the Sagittal                    Alignment Diagram.                -   Calculate: Lumbar Lordosis (LL), PI-LL, [Additional                    Lordosis for Sagittal Alignment Corrections] default                    value, Lumbar Apex, Roussouly Type. (Note: PT, SS,                    and PI typically does not change).            -   The calculation is triggered by any of the following 2                actions:                -   Performance of the Second Step above                -   Change to Lordosis Data Source on the Surgery                    Summary Object

    -   There are several calculation steps described, whose features        are further defined:        -   Computed values for Target Lordosis at a Level (for            Rothenfluh and Roussouly) can be calculated according to the            design of the Edit Lordosis (A3) modal window.        -   Computed values for Additional Lordosis for Sagittal            Alignment (Correction Rothenfluh), can be:            -   For the total (across all levels selected for fusion),                the computed value can be:                -   for any patient wherein the PI-LL is above the user                    defined threshold, the value can be [PI-LL] Minus                    the target.                -   For patients with PI-LL below the user defined                    threshold, the value can be zero (no null).                -   The default value of the edit box for this value on                    the Surgery Summary Object system can assume                    either: (1) the computed value above, if the user                    config specifies that the default IS to include                    Sagittal Alignment corrections, or (2) zero if the                    user config specifies that the default is to NOT                    include sagittal alignment corrections.            -   For segmental Additional Lordosis for Sagittal Alignment                Correction, can be calculated according to the design of                the Lordosis Distribution Calculations, Rothenfluh (B1)                modal window.        -   Computed values for Additional Lordosis for Sagittal            Alignment (Roussouly), system can:            -   Default for the Upper Arc and Lower Arc Additional                Lordosis for Sagittal Alignment Correction is zero            -   For segmental Additional Lordosis for Sagittal Alignment                Correction, can be calculated according to the design of                the Lordosis Distribution Calculations, Roussouly (B2)                modal window.        -   Computed values for [Segmental Correction for Anticipated            Subsidence]:            -   Can be calculated according to the design of the Edit                Correction for Anticipated Subsidence (C1) modal window.            -   The [Maximum Anticipated Anterior Subsidence] value can                be adjusted automatically or semi-automatically by the                software based on the difference between the plumb line                angle and the average angle (relative to the plumb line)                between the superior edge of the inferior vertebral body                and the inferior edge of the superior vertebral body.                Whenever this difference is less than the value                specified in user config, the [Maximum Anticipated                Anterior Subsidence] value is adjusted by an amount as                specified in user config, and then accordingly the                [Segmental Correction for Anticipated Subsidence] is                adjusted as well.        -   Lumbar Apex: This value can be calculated according to the            following formula pseudo-code:            -   If MIN (Abs (PEA_(L3)), Abs (PEA_(L4)), Abs                (PEA_(L5)))=Abs (PEA_(L3)) THEN LA=L3                -   ELSE If Abs (PEA_(L4))<Abs (PEA_(L5)), THEN LA=L4                -   ELSE LA=L5            -   SS=Sacral Slope            -   LA=Lumbar Apex            -   PEA_(LX)=Posterior edge angle (vs. plumb) for vertebral                body X        -   Roussouly Type: This value can be calculated according to            the following formula pseudo-code:            -   Roussouly typing is done based on two parameters, which                can agree to get a result:                -   If SS<35 AND LA=L5: Type text=“Type 1”                -   If SS<35 AND LA=L4: Type text=“Type 2”                -   If (SS≧35 AND ≦45) AND LA=L4: Type text=“Type 3”                -   If SS>45, AND LA=L3 or higher: Type text=“Type 4”            -   No result scenarios:                -   If SS<35 AND LA=L3: Type text=“ERROR: Type 1-2 based                    on Sacral Slope, but apex is not L4-L5”            -   If (SS≧35 AND ≦45) AND (LA=L5 OR L3): Type text=“ERROR:                Type 3 based on Sacral Slope, but apex is at [L5/L3] not                L4”                -   If SS>45 AND (LA=L4 or L5): Type text=“ERROR: Type 4                    based on Sacral Slope, but apex is at [L4/L5] not                    L3”            -   SS=Sacral Slope            -   LA=Lumbar Apex

Input File Features

-   -   The filenames that the system uses as input can be of the        filename type: “XX_MMDDYYYY”, where XX=First initial and last        initial, and MMDDYYYY is the patient's date of birth.    -   The following data can be available from the input fileset:        -   For Each study,            -   Atypical anatomy (L6, S2, no L5, etc.)? Boolean                TRUE/FALSE [NOTE: Currently, this is FALSE. In other                configurations, a variable might be used, which results                in a value other than FALSE].            -   PI, LL, SS, PT: Four different numbers. Non-integer                (double). Degree units.            -   Patient identifier:                -   Patient name: Two Strings (first, last). If there is                    a middle initial, it will be contained with the                    first name string. All strings are of unspecified                    length (i.e. length not controlled).                -   Date of birth: String of “YYYYMMDD”                -   Sex: String “M” or “F”            -   Template confirmation occurred? Boolean TRUE/FALSE                [NOTE: Currently, this will is FALSE. In other                configurations, a variable might be used, which results                in a value other than FALSE].        -   For Each level: From standing neutral, get:            -   In both % VBD and mm:                -   ADH, PDH, midline and Offset: Non-integer (double).                    For % VBD, 1%=1 (not 0.01).                -   Two instances of each data point (one in % VBD, one                    in mm)            -   lordosis and max lordosis: Non-integer (double). Degree                units.            -   Max/min mobility (ADH, PDH, Offset) at each level. This                is a set of min and max values for each of ADH, PDH, and                Offset. Non-integer (double). Millimeter units. In the                case of ADH and PDH, this is the millimeters to the min                and max displacement relative to the anterior superior                corner and posterior superior corner (respectively) of                the inferior vertebral body of a level.        -   For Each vertebral body: From standing neutral, get:            -   Angle measurements (vs. plumb): Angle of anterior edge,                posterior edge, superior endplate and posterior                endplates. Non-integer (double). Degree units.            -   Coordinates for each of the four corners of each                vertebral body. Non-integer (double) pair of (x,y)                coordinates, where (1,1) is the upper left most point.                Units will be in pixels or millimeters. Ideally the                system should be able to handle both. These coordinates                are used in the Sagittal balance diagram.            -   Length of each of the four edges. Non-integer (double).                Millimeter units.            -   Labels of each vertebral body, and the location of where                the labels system can go        -   Pdfs of report package (without images)        -   Image arrays. These are further specified below. The image            arrays contain the following data elements:            -   A set of 29 to 153 jpeg image files (without templates)            -   Two arrays of pointers to files contained in this image                set:                -   5×11 array for Specified Views                -   5×8 array for Min/Max views            -   A 5×18 array, each element containing:                -   two sets of 4 (x,y) points (8 sets in total), one                    each for the superior and inferior vertebral body.                    Each of these 8 sets of (x,y) points will be from an                    origin at the upper left hand corner of the                    associated image (the upper left point is (1,1)).                    Units will be in pixels or millimeters. Ideally the                    system should be able to handle both.                -   Labels of each vertebral body, and the location of                    where the labels should be placed on the image    -   Further specification of image arrays        -   Specific views:            -   This system can include up to all 11 views (standing                uncontrolled flex/ext/neutral, standing controlled                flex/ex/neutral, lying controlled flex/ex/neutral,                supine, prone). If views are missing they can be absent                from the image array.            -   Each view will have a pelvic view and an inferior view,                and some might additionally have superior view Therefore                this set of images is 22 min and 33 max.            -   A 5×11 array of pointers needs to be created that lists                all 5 Levels (L1/L2 through L5/S1) and all 11 views,                such that for each cell there is a pointer to the                appropriate image file that contains that vertebral body        -   Min/Max Views:            -   In preparing the data, for each of the 5 Levels (L1/L2                through L5/S1), the following specific images need to be                pulled and saved to the data structure:                -   Min lordosis, max lordosis (min lordosis is the                    largest absolute inter-vertebral angle, and max                    lordosis is the minimum absolute inter-vertebral                    angle)                -   Min ADH, Offset, and PDH. Max ADH, Offset and PDH.                -   This is a total of: [5 levels]×[4 min+4 max=8]=40                    views.                -   These views, plus any of the 11 that are not already                    included in the 40 views above, are saved to the                    data file. This means that a min of 29 (if all 11                    are included in the 40) and a max of 51 (if none of                    the 11 are included in the 40) images will be                    transferred over.                -   If there are superior as well as pelvic and inferior                    views, these numbers range from (i e min is still                    29, but max is actually 153)            -   A data structure needs to be created that is a 5×8 array                of pointers to image file names. This contains the                specific pointer to each of the min or max view for each                level.        -   Vertebral body location data            -   A 5×19 array needs to be created to contain the location                data for the four points of the two vertebral bodies                -   5=5 levels                -   19=all views (the 11 specified views+8 min/max                    views)            -   Each element in the 5×19 array will have 2 sets of four                (x,y) coordinates (relative to the upper left corner of                the image), one set for the superior vertebral body, and                one for the inferior vertebral body.

Alterations to the System

-   -   There can be a new user type: system user        -   Associated with a prescriber or a site        -   Multiple system users possible for each prescriber or site    -   The system user logs in via the portal, selects patients, then        get downloaded an encrypted zipped file containing a rendered        packet of data Once the download is complete, the system records        that this has been downloaded. It can be re-downloaded as many        times as the user would like.    -   The download packet itself is a data structure that gets used by        another program the system that runs on an unconnected console        computer. The detailed data structure specification is given        below:    -   The system will NOT render data packets if any of the following        conditions apply. The system will need to present an appropriate        error message to the user letting them know why the data packet        cannot be rendered, and what (if anything) can be done to remedy        the situation:        -   Templates have NOT been confirmed. Please confirm templates        -   Patient has anomalous anatomy. This type of patient cannot            be processed using system.        -   Incomplete data. The vertebral motion analysis study was            incomplete, and would need to be reprocessed to include data            that is currently missing to be able to render a system            file. [NOTE: All of the data listed below can be present            (i.e. no “n/r” is any cell). An exception is image data: If            all other data is complete but some expected views are            missing, then the data can be rendered.]        -   A grid calibration was not done in the vertebral motion            analysis study, which may be used for processing using            system. The vertebral motion analysis study can be re-run,            reprocessed, and then a system file can be rendered.        -   A millimeter calibration marker was either not included, or            was not usable. The vertebral motion analysis study needs to            be re-run, reprocessed, and then a system file can be            rendered.

In engaging the systems and methods according to aspects of thedisclosed subject matter the user may engage in one or more usesessions. Each use session may include a training session and/orsurgical session. Additional data relating to performance may becompared from one or more use sessions for application in other surgicalprocedures.

A fourth aspect of the disclosure is a method of modeling and projectingvarious loads across orthopedic implants prior to and during surgery. Aninput to this system is data regarding the position of patient spinaland other anatomy in various positions, including those that representtarget physical conditions such as unassisted standing neutral postures.Knowing the spatial location of this anatomy, especially when theselocations incorporate data that enables the anatomy to be placed inspace relative to a gravitational plumb line, can be used to projectforces at a specific level, and within a level at specific points. Toacquire this data relative to a plumb line, a measurement system is usedthat incorporates an ability to image a plumb line, and thatincorporates the ability to derive positional data for each vertebralbody relative to this plumb line. See FIGS. 13A-C.

These forces can be projected using simple geometric relationships whichaccount for normal gravitational loads that would occur, for example,during unassisted standing neutral postures. These forces could then bedifferentially projected post-operatively, assuming a specific type ofgeometry of the surgical construct, then substituting the pre-operativegeometry with the assumed post-operative geometry at a surgical level,to project a new spatial relationship between spinal levels, and thus toproject how forces may change as a consequence of the change in geometryat the operated level.

These forces can be projected in other ways that incorporates: (1)biomechanical modelling using standard biomechanical modelling software,(2) additional patient-specific parameters such as the cross sectionalarea of a muscle or muscle group in radiographic images, other imagingparameters, surface and/or needle electromyography and any associatedmeasurements (such as applied force during surface electromyogram (EMG)data collection during isometric or isokinetic or some other form offunctional testing).

These forces can be projected in a way that is relative, such that asingle force measurement is given as a “high, medium, or low”. Thesegroupings may be defined by user settable thresholds. These forces willinclude sheer forces and compressive forces, at the anterior margin andthe posterior margin of the implant (for a total of four forceparameters. These force projections may incorporate specific informationabout the placement of a specific implant, such that intra-operativelyimplant placement can be input into the system to determine if anyabnormally high forces are detected for a specific surgical construct.

These forces projections may incorporate target surgical constructgeometry, as may be specified by a user in some way, to project howforces would change and what type of forces may result from a specifictype of surgical construct.

The systems and methods according to aspects of the disclosed subjectmatter may utilize a variety of computer and computing systems,communications devices, networks and/or digital/logic devices foroperation. Each may, in turn, be configurable to utilize a suitablecomputing device which can be manufactured with, loaded with and/orfetch from some storage device, and then execute, instructions thatcause the computing device to perform a method according to aspects ofthe disclosed subject matter.

A computing device can include without limitation a desktop computingdevice, a networked computing device, a mobile user device such as amobile phone, a smart phone and a cellular phone, a personal digitalassistant (“PDA”), a tablet, a laptop and the like. In at least someconfigurations, a user can access and manipulate data via a browserapplication over a network, such as the Internet, to view and interactwith digital content, such as screen displays. A display includes, forexample, an interface that allows a visual presentation of data from acomputing device. Access could be over or partially over other forms ofcomputing and/or communications networks. A user may access aweb-browser, e.g., to provide access to applications and data and othercontent located on a web-site or a web-page of a web-site.

A suitable computing device may include a processor to perform logic andother computing operations, e.g., a stand-alone computer processing unit(“CPU”), or hard wired logic as in a microcontroller, or a combinationof both, and may execute instructions according to its operating systemand the instructions to perform the steps of the method, or elements ofthe process. The user's computing device may be part of a network ofcomputing devices and the methods of the disclosed subject matter may beperformed by different computing devices associated with the network,perhaps in different physical locations, cooperating or otherwiseinteracting to perform a disclosed method. For example, a user'sportable computing device may run an app alone or in conjunction with aremote computing device, such as a server on the Internet. For purposesof the present application, the term “computing device” includes any andall of the above discussed logic circuitry, communications devices anddigital processing capabilities or combinations of these.

Certain embodiments of the disclosed subject matter may be described forillustrative purposes as steps of a method which may be executed on acomputing device executing software, and illustrated, by way of exampleonly, as a block diagram of a process flow. Such may also be consideredas a software flow chart. Such block diagrams and like operationalillustrations of a method performed or the operation of a computingdevice and any combination of blocks in a block diagram, can illustrate,as examples, software program code/instructions that can be provided tothe computing device or at least abbreviated statements of thefunctionalities and operations performed by the computing device inexecuting the instructions. Some possible alternate implementation mayinvolve the function, functionalities and operations noted in the blocksof a block diagram occurring out of the order noted in the blockdiagram, including occurring simultaneously or nearly so, or in anotherorder or not occurring at all. Aspects of the disclosed subject mattermay be implemented in parallel or seriatim in hardware, firmware,software or any combination(s) of these, co-located or remotely located,at least in part, from each other, e.g., in arrays or networks ofcomputing devices, over interconnected networks, including the Internet,and the like.

The instructions may be stored on a suitable “machine readable medium”within a computing device or in communication with or otherwiseaccessible to the computing device. As used in the present application amachine readable medium is a tangible storage device and theinstructions are stored in a non-transitory way. At the same time,during operation, the instructions may at some times be transitory,e.g., in transit from a remote storage device to a computing device overa communication link. However, when the machine readable medium istangible and non-transitory, the instructions will be stored, for atleast some period of time, in a memory storage device, such as a randomaccess memory (RAM), read only memory (ROM), a magnetic or optical discstorage device, or the like, arrays and/or combinations of which mayform a local cache memory, e.g., residing on a processor integratedcircuit, a local main memory, e.g., housed within an enclosure for aprocessor of a computing device, a local electronic or disc hard drive,a remote storage location connected to a local server or a remote serveraccess over a network, or the like. When so stored, the software willconstitute a “machine readable medium,” that is both tangible and storesthe instructions in a non-transitory form. At a minimum, therefore, themachine readable medium storing instructions for execution on anassociated computing device will be “tangible” and “non-transitory” atthe time of execution of instructions by a processor of a computingdevice and when the instructions are being stored for subsequent accessby a computing device.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. A machine readable medium containing instructionsstored on a non-transitory computer readable medium that, when executedby a computing device, cause the computing device to perform a method,the method comprising: receiving an input dataset comprising one or moremedical images containing a spine level of interest for a patient; andgenerating an optimized anatomical dataset for the spine level ofinterest wherein the optimized anatomical data set comprises one or moreof a target disc height, a target anterior-posterior offset, and atarget lordosis angle, and further wherein the step of generating anoptimized anatomical dataset for the spine level of interest comprisesthe steps of: identifying zero, one, or more visible spine levels in theone or more medical images to exclude from analysis; and accessing oneor more image-derived measurements of a disc height measurement, ananterior-posterior offset measurement, and a sagittal lordosis anglemeasurement for one or more non-excluded spine levels; and applying afunction to the one or more measurements from accessing one or moreimage-derived measurements to generate an optimized value for the spinelevel of interest for one or more of the target disc height, the targetanterior-posterior offset, and the target lordosis angle.
 2. The machinereadable medium of claim 1, wherein the function receives an input andapplies one or more adjustments to correct for an assumed post-operativesubsidence of an interbody device over time.
 3. The machine readablemedium of claim 2, wherein the one or more adjustments is a disc heightadjustment, an anterior-posterior offset adjustment, and a lordosisangle adjustment.
 4. The machine readable medium of claim 1, wherein theone or more medical images excluded from analysis is excludedindependently for one or more of an excluded disc height measurement, anexcluded anterior-posterior offset, and an excluded sagittal lordosisangle.
 5. The machine readable medium of claim 1, wherein the functionis one of an average function and a distribution function, and furtherwherein an input is selected from a medical literature.
 6. The machinereadable medium of claim 1, wherein a surgical navigation system usermay specify a gross lordosis target for an entire region of a spine andwherein the function distributes one or more gross lordosis regionaltargets across a user-specified set of levels targeted for fusionsurgery.
 7. A processor for generating estimates of a weight carried ata spine level of interest, wherein the processor is programmed toexecute: accessing an input dataset for a patient comprising a weight ofthe patient, one or more image-derived measurements of a spatialrelationships between two or more vertebral bodies visible within one ormore images; allowing a user to specify a spine level of interest; andprojecting an estimated weight carried at the spine level of interestby: looking-up one or more values from a previously published massdistribution function, wherein the mass distribution function comprisesa set of percentage values associated with various bodily regions suchthat the sum of the set of percentage values equals 100%; summing x fromthe mass distribution function elements for all bodily regions cranialto a spinal region of interest; calculating y from the image-derivedmeasurements of the spatial relationships between vertebral bodies fromthe input dataset, by determining an estimated percentage of the regionof interest that is cranial to a spinal level of interest; summing x andy; and multiplying the sum of x and y by a weight of the patient todetermine the weight carried at the spine level of interest.
 8. Theprocessor for generating estimates of the weight carried at the spinelevel of interest of claim 7 further comprising: calculating a sheer anda compressive component of the weight carried at the spine level ofinterest, using the image-derived measurements of the angulation betweenvertebral body endplates and a plumb line.
 9. The processor forgenerating estimates of the weight carried at the spine level ofinterest of claim 7 wherein the input dataset contains patient-specificdata and wherein the computational routine incorporates a lookupfunction that returns a mass distribution which is a function of thepatient-specific data.
 10. The processor for generating estimates of theweight carried at the spine level of interest of claim 9 wherein thepatient-specific data is selected from age, gender, and height.
 11. Theprocessor for generating estimates of the weight carried at the spinelevel of interest of claim 7 wherein previously published massdistribution function is one selected by the user from among a set ofavailable functions.
 12. A processor for use with surgical navigationsystems used for spinal surgery wherein the processor is programmed toexecute: receiving an input dataset comprising one or more medicalimages containing a spine level of interest; and generating measurementsof an operating range of the spine level of interest, comprisingmeasurements of at least one of a minimum linear displacement between apair of adjacent vertebral body corner-points from the spine level ofinterest and a maximum linear displacement between a pair of adjacentvertebral body corner-points from the spine level of interest byexecuting a computational process comprising: accessing one or moremedical images containing the spine level of interest from the inputdataset, and further accessing one or more measurements from each imageof at least one of the minimum linear displacement and the maximumlinear displacement; and applying at least one of a maximum function anda minimum function to the measurement sets to determine a maximum lineardisplacement value for a pair of adjacent corner points and a minimumlinear displacement values for the pair of adjacent corner-points; andrendering data usable by a surgical navigation system based on theoperating range measurements.
 13. The processor of claim 12, wherein therendering of data usable by a surgical navigation system supports avisual display of the operating range measurements by the surgicalnavigation system.
 14. The processor of claim 12, wherein the datarendered triggers an alert to a surgical navigation system user when theoperating range measurement for the spine level of interest is outsideof a user-determined threshold value.
 15. A processor for use with asurgical navigation system used for spinal surgery that wherein theprocessor is programmed to execute: receiving an input datasetcomprising one or more medical images, wherein each medical imageincludes an image of a spinal level of interest, one or moreimage-derived measurements for each medical image wherein the one ormore image-derived measurements are selected from an alignmentmeasurement, a lordosis measurement, a translation measurement, anangulation measurement, and a disc height measurement; allowing a userto specify a data presentation by selecting one or more of theimage-derived measurements and by further selecting at least one of aminimum value and a maximum value; identifying a specific image viewcorresponding to the data presentation wherein an output of anidentification process is a reference to an image that corresponds tothe user specified data presentation; and generating comparative databetween a current status of the patient wherein the generatedcomparative data uses a measurement from one or more image capturedintra-operatively via the surgical navigation system and the datapresentation.
 16. The processor of claim 15, wherein the image-derivedmeasurement includes measurements that are derivative to themeasurements included in the input dataset.
 17. The processor of claim15, wherein the comparative data generated includes one or more of agenerated image with a template, a generated image without a template,and a generated image compiled from multiple imaging modalities.
 18. Aprocessor for use with a surgical navigation system used for spinalsurgery wherein the processor is programmed to execute: receiving apre-operative dataset and an inter-operative dataset, wherein each ofthe pre-operative dataset and inter-operative dataset comprises one ormore medical images containing a spine region of interest as well as adataset of location values associated with a four-point registration ofeach vertebral body visible within the spine region of interest;allowing a user of the surgical navigation system to specify an inputdataset for each vertebral body pair within the spine region ofinterest; and rendering a block diagram of a spine, by using thefour-point registration dataset from the input dataset selected by theuser.